AVJ-514 Japan Trial

A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02520310

Enrollment

Registered

2015-08-11

Start date

2015-09-07

Completion date

2021-05-31

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Stenosis With Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation

Keywords

Mitral Regurgitation, mitral valve surgery, AVJ-514 Delivery System, Symptomatic Heart Failure, Heart Valve Disease

Brief summary

The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.

Detailed description

This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team. Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.

Interventions

DEVICEAVJ-514

Patients receiving AVJ-514 device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria: 1. Age 20 years or older. 2. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE. 3. Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). 4. New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV. 5. Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors: * Porcelain aorta or mobile ascending aortic atheroma * Post-radiation mediastinum * Previous mediastinitis * Functional MR with LVEF \< 40% * Over 75 years old with LVEF \< 40% * Re-operation with patent grafts * Two or more prior cardiothoracic surgeries * Hepatic cirrhosis * Other surgical risk factor(s) 6. Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE. 7. Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration. 8. The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-514. If a secondary jet exists, it must be considered clinically insignificant. 9. Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician. 10. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.

Exclusion criteria

Subjects must not meet any of the following

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Acute Procedure Success (APS)	On day 0 (the day of procedure)	APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

Secondary

Measure	Time frame	Description
Change in SF-36 QoL Scores From Baseline	At 24 months	—
Number of Participants Undergoing Mitral Valve Surgery	Through 5 years	—
Number of Participants With Additional Mitra Clip Device Intervention	Through 5 years	—
Length of Rehabilitation Stay	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	Cumulative days of rehabilitation stay during hospitalization.
Percentage of Participants With Major Adverse Events (MAE) at 30 Days	30 days	MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Percentage of Participants With MAE at 1 Year	1 year	MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access	30 days	MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: * Death * Stroke * Myocardial infarction * Renal failure * Non-elective cardiovascular surgery for device or procedure related adverse events
Number of Participants With Mitral Valve Stenosis Requiring Surgery	1 year	Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.
Number of Participants With Mitral Valve Stenosis Not Requiring Surgery	1 year	Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.
Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery	1 year	SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery	1 year	SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Number of Participants With Iatrogenic Atrial Septal Defect	30 days	Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.
Percentage of Participants With Device Implant Rate	On the day of procedure	Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.
Device Procedure Time	On the day of procedure	Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Total Procedure Time	On the day of procedure	Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.
Device Time	On the day of procedure	Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.
Fluoroscopy Duration	On the day of procedure	Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.
Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)
Length of Hospital Stay Excluding Rehabilitation Stay	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)
Percentage of Participants With Discharge Status	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	Location to which subject was discharged (home or another facility).
Length of Stay (Not at Baseline Facility)	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.
Number of Participants With Mitral Regurgitation (MR) Severity Grade	At baseline (Within 14 days prior to the AVJ-514 procedure)	Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Number of Participants With MR Severity Grade	At Discharge (≤ 14.4 ± 8.5 days post index procedure)	Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
MR Severity Grade	24 months	Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Regurgitant Volume (RV)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Fraction (RF)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Left Ventricular End Diastolic Volume (LVEDV)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Dimension (LVEDD)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Systolic Dimension (LVESD)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Pulmonary Artery Systolic Pressure (PASP)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Mitral Valve Area (MVA)	At baseline (Within 14 days prior to the AVJ-514 procedure)	It is the orifice area of the mitral valve.
Mitral Valve Area(MVA)	6 months	It is the orifice area of the mitral valve.
Mean Mitral Valve Pressure Gradient (MVG)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.
Systolic Anterior Motion of the Mitral Valve (Present or Absent)	24 months	Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Forward Stroke Volume (FSV)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Defined as the volume of blood pumped from the left ventricle per heartbeat.
Cardiac Output (CO)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Index (CI)	At baseline (Within 14 days prior to the AVJ-514 procedure)	Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Number of Participants With All-cause Mortality	1 year	—
All-cause Mortality	24 months	—
Number of Participants With the Primary Safety Composite of MAE at 1 Year	12 months	MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.
Freedom From the Components of the Primary Safety Composite of MAE	24 months	MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Number of Patients With New York Heart Association (NYHA) Functional Class	At baseline (Within 14 days prior to the AVJ-514 procedure)	Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With NYHA Functional Class	30 days	Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
NYHA Functional Class	24 months	Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores	At baseline (Within 14 days prior to the AVJ-514 procedure)	KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores	30 days	KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Change in KCCQ QoL Scores From Baseline to 1 Year	Baseline to 1 Year	KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
SF-36 QoL Scores	At baseline (Within 14 days prior to the AVJ-514 procedure)	The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for congestive heart failure (CHF) population are 31 & 46, respectively.
Six Minute Walk Test (6MWT) Distance	At baseline (Within 14 days prior to the AVJ-514 procedure)	The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year	Baseline to 1 year	—
Changes in Six Minute Walk Test (6MWT) Distance From Baseline	At 24 months	—
Number of Participants With Mitral Valve Surgery	30 days	Surgical access to repair or replace the mitral valve. Measured per occurrence.
Number of Participants With Additional AVJ-514 Device Intervention	30 days	Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Number of Hospitalizations and Reason for Hospitalization	1 year post index procedure	—
Number of Hospitalizations	24 months	—
Number of Participants With Mitral Stenosis	1 year	Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Change in SF-36 QoL Scores From Baseline to 1 Year	From baseline to 1 year	—
Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention	12 months	Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Clinically Significant ASD That Requires Intervention	24 months	Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Major Bleeding	30 days	Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: * Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding * Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents * Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Number of Participants With Usage of Concomitant Cardiac Medications	At baseline (Within 14 days prior to the AVJ-514 procedure)	Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior	1 Year Pre and Post Index Procedure	—
Number of Participants With Device Embolization Requiring Surgery	1 year	Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Number of Participants With Device Embolization Not Requiring Surgery	1 year	Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Mitral Stenosis	24 months	Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.

Countries

Japan

Participant flow

Recruitment details

A total of 30 subjects were enrolled at 6 japan sites from September 7, 2015 to June 14, 2016.

Pre-assignment details

Prior to the procedure,subjects were assessed to ensure there was no significant change in the subject's overall condition (e.g.stroke,MI,active infection,etc.) that would preclude treatment. If the subject experienced any significant change, the subject was treated&reassessed for the clinical investigation.They were not considered registered.

Participants by arm

Arm	Count
AVJ-514 The AVJ-514 system: Patients receiving AVJ-514 device	30
Total	30

Withdrawals & dropouts

Period	Reason	FG000
At 1 Year Clinical Follow-up	Withdrawal by Subject	1
AT 3 Year Clinical Follow-up	Death	2
AT 3 Year Clinical Follow-up	Withdrawal by Subject	2
AT 4 Year Clinical Follow-up	Death	1
AT 4 Year Clinical Follow-up	missed visit	1
At 6 Months Clinical Follow-up	Death	1

Baseline characteristics

Characteristic	AVJ-514
Age, Continuous	80.4 years STANDARD_DEVIATION 7
Region of Enrollment Japan	30 Participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	23 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	5 / 30
other Total, other adverse events	30 / 30
serious Total, serious adverse events	27 / 30

Outcome results

Primary

Number of Participants With Acute Procedure Success (APS)

APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

Time frame: On day 0 (the day of procedure)

Population: ITT population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Acute Procedure Success (APS)	26 Participants

Secondary

All-cause Mortality

Time frame: 4 years

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	All-cause Mortality	5 Participants

Secondary

All-cause Mortality

Time frame: 5 years

Secondary

All-cause Mortality

Time frame: 24 months

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	All-cause Mortality	1 Participants

Secondary

All-cause Mortality

Time frame: 3 years

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	All-cause Mortality	3 Participants

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2 L/min/m^2	Standard Deviation 0.4

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2.3 L/min/m^2	Standard Deviation 0.8

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2.6 L/min/m^2	Standard Deviation 1.1

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	4.1 L/min/m^2	Standard Deviation 5.5

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	3.6 L/min/m^2	Standard Deviation 5.7

Secondary

Cardiac Index (CI)

Time frame: 5 years

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2.0 L/min/m^2	Standard Deviation 0.5

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2.1 L/min/m^2	Standard Deviation 0.7

Secondary

Cardiac Index (CI)

Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Index (CI)	2.1 L/min/m^2	Standard Deviation 0.6

Secondary

Cardiac Output (CO)

Time frame: 5 years

Secondary

Cardiac Output (CO)

Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	3.1 L/min	Standard Deviation 0.7

Secondary

Cardiac Output (CO)

Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	3.5 L/min	Standard Deviation 1.1

Secondary

Cardiac Output (CO)

Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	3.1 L/min	Standard Deviation 0.8

Secondary

Cardiac Output (CO)

Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	3.0 L/min	Standard Deviation 0.7

Secondary

Cardiac Output (CO)

Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	6.3 L/min	Standard Deviation 9.3

Secondary

Cardiac Output (CO)

Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	5.6 L/min	Standard Deviation 8.9

Secondary

Cardiac Output (CO)

Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	3.2 L/min	Standard Deviation 1.2

Secondary

Cardiac Output (CO)

Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Cardiac Output (CO)	4.1 L/min	Standard Deviation 1.8

Secondary

Change in KCCQ QoL Scores From Baseline to 1 Year

KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.

Time frame: Baseline to 1 Year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Change in KCCQ QoL Scores From Baseline to 1 Year	6.7 units on a scale	Standard Deviation 13.5

Secondary

Change in SF-36 QoL Scores From Baseline

Time frame: At 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	Change in SF-36 QoL Scores From Baseline	Role Physical (RP)	4.7 score on a scale	Standard Deviation 14.5
AVJ-514	Change in SF-36 QoL Scores From Baseline	Bodily Pain (BP)	0.7 score on a scale	Standard Deviation 13.3
AVJ-514	Change in SF-36 QoL Scores From Baseline	General Health (GH)	2.0 score on a scale	Standard Deviation 8.7
AVJ-514	Change in SF-36 QoL Scores From Baseline	Physical Function (PF)	0.7 score on a scale	Standard Deviation 12.4

Secondary

Change in SF-36 QoL Scores From Baseline to 1 Year

Time frame: From baseline to 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	Change in SF-36 QoL Scores From Baseline to 1 Year	Physical Component Summary	3.7 units on a scale	Standard Deviation 12.5
AVJ-514	Change in SF-36 QoL Scores From Baseline to 1 Year	Mental Component Summary	1.4 units on a scale	Standard Deviation 8.5

Secondary

Changes in Six Minute Walk Test (6MWT) Distance From Baseline

Time frame: At 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Changes in Six Minute Walk Test (6MWT) Distance From Baseline	-40.8 meters	Standard Deviation 86.9

Secondary

Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year

Time frame: Baseline to 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year	1.4 meters	Standard Deviation 79.1

Secondary

Device Procedure Time

Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.

Time frame: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Device Procedure Time	206.4 Minutes	Standard Deviation 84.06

Secondary

Device Time

Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.

Time frame: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Device Time	126.6 Minutes	Standard Deviation 79.57

Secondary

Fluoroscopy Duration

Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.

Time frame: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Fluoroscopy Duration	62.5 Minutes	Standard Deviation 31.11

Secondary

Forward Stroke Volume (FSV)

Time frame: 5 years

Secondary

Forward Stroke Volume (FSV)

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Forward Stroke Volume (FSV)	52.6 ml	Standard Deviation 14.7

Secondary

Forward Stroke Volume (FSV)

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Forward Stroke Volume (FSV)	46.8 ml	Standard Deviation 12.3

Secondary

Forward Stroke Volume (FSV)

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Forward Stroke Volume (FSV)	49.2 ml	Standard Deviation 9.6

Secondary

Forward Stroke Volume (FSV)

Time frame: 3 years

Secondary

Forward Stroke Volume (FSV)

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Forward Stroke Volume (FSV)	49.6 ml	Standard Deviation 13.8

Secondary

Forward Stroke Volume (FSV)

Time frame: 4 years

Secondary

Forward Stroke Volume (FSV)

Time frame: 24 months

Secondary

Forward Stroke Volume (FSV)

Defined as the volume of blood pumped from the left ventricle per heartbeat.

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Forward Stroke Volume (FSV)	56.4 ml	Standard Deviation 12.9

Secondary

Freedom From the Components of the Primary Safety Composite of MAE

Time frame: 3 years

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Death	3 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Stroke	1 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Myocardial Infarction	0 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Renal Failure	2 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Non-elective cardiovascular surgery	0 Participants

Secondary

Freedom From the Components of the Primary Safety Composite of MAE

Time frame: 5 years

Secondary

Freedom From the Components of the Primary Safety Composite of MAE

Time frame: 24 months

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Death	1 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Stroke	1 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Myocardial Infarction	0 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Renal Failure	1 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Non-Elective Cardiovascular Sugery	0 Participants

Secondary

Freedom From the Components of the Primary Safety Composite of MAE

Time frame: 4 years

Population: This study contains only one group. All patients received AVJ-514 device - MitraClip NT System.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Death	5 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Stroke	1 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Myocardial Infarction	0 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Renal Failure	2 Participants
AVJ-514	Freedom From the Components of the Primary Safety Composite of MAE	Non-elective Cardiovascular Surgery for device or procedure related Adverse Event	0 Participants

Secondary

Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores	71.8 units on a scale	Standard Deviation 14.9

Secondary

KCCQ QoL Scores

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.

Time frame: 4 years

Secondary

KCCQ QoL Scores

Time frame: 5 years

Secondary

KCCQ QoL Scores

Time frame: 3 years

Secondary

KCCQ QoL Scores

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	KCCQ QoL Scores	80.1 score on a scale	Standard Deviation 17.4

Secondary

KCCQ QoL Scores

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	KCCQ QoL Scores	79.6 units on a scale	Standard Deviation 20.5

Secondary

KCCQ QoL Scores

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	KCCQ QoL Scores	79.3 units on a scale	Standard Deviation 18.7

Secondary

KCCQ QoL Scores

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	KCCQ QoL Scores	81.3 units on a scale	Standard Deviation 17.1

Secondary

Left Ventricular Ejection Fraction (LVEF)

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	44.5 percentage of Ejection Fraction	Standard Deviation 17.8

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	44.8 percentage of ejection fraction	Standard Deviation 15.9

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	47.0 percentage of ejection fraction	Standard Deviation 15.1

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	48.7 percentage of ejection fraction	Standard Deviation 14.2

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	49.5 percentage of ejection fraction	Standard Deviation 15.2

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	49.8 percentage of ejection fraction	Standard Deviation 12.6

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	45.0 percentage of ejection fraction	Standard Deviation 11.8

Secondary

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular Ejection Fraction (LVEF)	50.2 percentage of ejection fraction	Standard Deviation 12.8

Secondary

Left Ventricular Ejection Fraction (LVEF)

Time frame: 5 years

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Time frame: 5 years

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.7 cm	Standard Deviation 0.9

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.6 cm	Standard Deviation 1

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.7 cm	Standard Deviation 0.9

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.4 cm	Standard Deviation 0.8

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.6 cm	Standard Deviation 0.9

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.5 cm	Standard Deviation 0.8

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.7 cm	Standard Deviation 0.9

Secondary

Left Ventricular End Diastolic Dimension (LVEDD)

Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Dimension (LVEDD)	5.4 cm	Standard Deviation 0.8

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	126.4 mL	Standard Deviation 40.5

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	144.1 mL	Standard Deviation 47.2

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	130.0 mL	Standard Deviation 37.9

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	134.6 mL	Standard Deviation 40.7

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	127.0 mL	Standard Deviation 43.4

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	147.3 ml	Standard Deviation 59.2

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	144.6 ml	Standard Deviation 61.4

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Diastolic Volume (LVEDV)	138.9 ml	Standard Deviation 63.6

Secondary

Left Ventricular End Diastolic Volume (LVEDV)

Time frame: 5 years

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.1 cm	Standard Deviation 1.2

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.1 cm	Standard Deviation 1.1

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.3 cm	Standard Deviation 1.2

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.4 cm	Standard Deviation 1.3

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the site.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.4 cm	Standard Deviation 1.2

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Time frame: 5 years

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.1 cm	Standard Deviation 1.2

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.1 cm	Standard Deviation 1.2

Secondary

Left Ventricular End Systolic Dimension (LVESD)

Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Dimension (LVESD)	4.1 cm	Standard Deviation 1.1

Secondary

Left Ventricular End Systolic Volume (LVESV)

Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	74.1 mL	Standard Deviation 34.3

Secondary

Left Ventricular End Systolic Volume (LVESV)

Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	83.7 ml	Standard Deviation 57.3

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 5 years

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	72.6 ml	Standard Deviation 36.5

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	68.7 mL	Standard Deviation 32.2

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	72.5 mL	Standard Deviation 39.9

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	69.5 mL	Standard Deviation 38.8

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	83.9 ml	Standard Deviation 51.9

Secondary

Left Ventricular End Systolic Volume (LVESV)

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Left Ventricular End Systolic Volume (LVESV)	87.0 ml	Standard Deviation 53.3

Secondary

Length of Hospital Stay Excluding Rehabilitation Stay

Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Length of Hospital Stay Excluding Rehabilitation Stay	14.4 Days	Standard Deviation 8.53

Secondary

Length of Rehabilitation Stay

Cumulative days of rehabilitation stay during hospitalization.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Length of Rehabilitation Stay	4.9 Days	Standard Deviation 3.12

Secondary

Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)

Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)	36.8 Hours	Standard Deviation 36.31

Secondary

Length of Stay (Not at Baseline Facility)

If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Length of Stay (Not at Baseline Facility)	2.6 Days	Standard Deviation 2.66

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.8 mmHg	Standard Deviation 1.2

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.0 mmHg	Standard Deviation 1.4

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.6 mmHg	Standard Deviation 1.5

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.6 mmHg	Standard Deviation 1.3

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Time frame: 5 years

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	2.4 mmHg	Standard Deviation 0.7

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.6 mmHg	Standard Deviation 2

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	3.7 mmHg	Standard Deviation 1.8

Secondary

Mean Mitral Valve Pressure Gradient (MVG)

Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mean Mitral Valve Pressure Gradient (MVG)	4.1 mmHg	Standard Deviation 2.2

Secondary

Mitral Stenosis

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Time frame: 5 years

Secondary

Mitral Stenosis

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.

Time frame: 24 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Mitral Stenosis	3 Participants

Secondary

Mitral Stenosis

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Time frame: 3 years

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Mitral Stenosis	3 Participants

Secondary

Mitral Stenosis

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Time frame: 4 years

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Mitral Stenosis	3 Participants

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the mitral valve.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	6.0 cm^2	Standard Deviation 1.1

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the mitral valve.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	2.8 cm^2	Standard Deviation 0.6

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the mitral valve.

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	2.8 cm^2	Standard Deviation 0.8

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the Mitral Valve

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	2.9 cm^2	Standard Deviation 0.8

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the Mitral Valve.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	3.6 cm^2	Standard Deviation 1.9

Secondary

Mitral Valve Area (MVA)

It is the orifice area of the Mitral Valve.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area (MVA)	2.9 cm^2	Standard Deviation 0.7

Secondary

Mitral Valve Area (MVA)

Time frame: 5 years

Secondary

Mitral Valve Area(MVA)

It is the orifice area of the mitral valve.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area(MVA)	2.3 cm^2	Standard Deviation 0.6

Secondary

Mitral Valve Area(MVA)

It is the orifice area of the mitral valve.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Mitral Valve Area(MVA)	2.4 cm^2	Standard Deviation 0.6

Secondary

MR Severity Grade

Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	MR Severity Grade	MR 0	0 Participants
AVJ-514	MR Severity Grade	MR 1+	12 Participants
AVJ-514	MR Severity Grade	MR 2 +	13 Participants
AVJ-514	MR Severity Grade	MR 3+	2 Participants
AVJ-514	MR Severity Grade	MR 4+	1 Participants

Secondary

MR Severity Grade

Time frame: 5 years

Secondary

MR Severity Grade

Time frame: 4 years

Population: All available data is reported

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	MR Severity Grade	MR 0+	0 Participants
AVJ-514	MR Severity Grade	MR 1+	7 Participants
AVJ-514	MR Severity Grade	MR 2+	9 Participants
AVJ-514	MR Severity Grade	MR 3+	5 Participants
AVJ-514	MR Severity Grade	MR 4+	0 Participants
AVJ-514	MR Severity Grade	Not Available	1 Participants

Secondary

MR Severity Grade

Time frame: 3 years

Population: All subjects woth availble data

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	MR Severity Grade	MR 0+	0 Participants
AVJ-514	MR Severity Grade	MR 1+	10 Participants
AVJ-514	MR Severity Grade	MR 2+	10 Participants
AVJ-514	MR Severity Grade	MR 3+	4 Participants
AVJ-514	MR Severity Grade	MR 4 +	0 Participants

Secondary

Number of Hospitalizations

Time frame: 3 years

Secondary

Number of Hospitalizations

Time frame: 5 years

Secondary

Number of Hospitalizations

Time frame: 4 years

Secondary

Number of Hospitalizations

Time frame: 24 months

Secondary

Number of Hospitalizations and Reason for Hospitalization

Time frame: 1 year post index procedure

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Hospitalizations and Reason for Hospitalization	Cardiovascular	2 Participants
AVJ-514	Number of Hospitalizations and Reason for Hospitalization	Non-cardiovascular	9 Participants
AVJ-514	Number of Hospitalizations and Reason for Hospitalization	Heart failure	4 Participants

Secondary

Number of Participants Undergoing Mitral Valve Surgery

Time frame: Through 5 years

Secondary

Number of Participants With Additional AVJ-514 Device Intervention

Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Additional AVJ-514 Device Intervention	0 Participants

Secondary

Number of Participants With Additional AVJ-514 Device Intervention

Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Additional AVJ-514 Device Intervention	0 Participants

Secondary

Number of Participants With Additional Mitra Clip Device Intervention

Time frame: Through 5 years

Secondary

Number of Participants With All-cause Mortality

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With All-cause Mortality	1 Participants

Secondary

Number of Participants With Clinically Significant ASD That Requires Intervention

Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)

Time frame: 24 months

Secondary

Number of Participants With Clinically Significant ASD That Requires Intervention

Time frame: 5 years

Secondary

Number of Participants With Clinically Significant ASD That Requires Intervention

Time frame: 4 years

Secondary

Number of Participants With Clinically Significant ASD That Requires Intervention

Time frame: 3 years

Secondary

Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention

Time frame: 12 months

Secondary

Number of Participants With Device Embolization Not Requiring Surgery

Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Device Embolization Not Requiring Surgery	0 Participants

Secondary

Number of Participants With Device Embolization Requiring Surgery

Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Device Embolization Requiring Surgery	0 Participants

Secondary

Number of Participants With Iatrogenic Atrial Septal Defect

Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Iatrogenic Atrial Septal Defect	0 Participants

Secondary

Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access

MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: * Death * Stroke * Myocardial infarction * Renal failure * Non-elective cardiovascular surgery for device or procedure related adverse events

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access	0 Participants

Secondary

Number of Participants With Major Bleeding

Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: * Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding * Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents * Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Major Bleeding	3 Participants

Secondary

Number of Participants With Major Bleeding

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Major Bleeding	3 Participants

Secondary

Number of Participants With Mitral Regurgitation (MR) Severity Grade

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Regurgitation (MR) Severity Grade	MR Severity Grade 0	0 Participants
AVJ-514	Number of Participants With Mitral Regurgitation (MR) Severity Grade	MR Severity Grade 1+	0 Participants
AVJ-514	Number of Participants With Mitral Regurgitation (MR) Severity Grade	MR Severity Grade 2+	0 Participants
AVJ-514	Number of Participants With Mitral Regurgitation (MR) Severity Grade	MR Severity Grade 3+	24 Participants
AVJ-514	Number of Participants With Mitral Regurgitation (MR) Severity Grade	MR Severity Grade 4+	6 Participants

Secondary

Number of Participants With Mitral Stenosis

Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Stenosis	3 Participants

Secondary

Number of Participants With Mitral Valve Stenosis Not Requiring Surgery

Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Valve Stenosis Not Requiring Surgery	3 Participants

Secondary

Number of Participants With Mitral Valve Stenosis Requiring Surgery

Defined as a mitral valve orifice of less than 1.5 cm\^2 as measured by the Echocardiography Core Laboratory.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Valve Stenosis Requiring Surgery	0 Participants

Secondary

Number of Participants With Mitral Valve Surgery

Surgical access to repair or replace the mitral valve. Measured per occurrence.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Valve Surgery	0 Participants

Secondary

Number of Participants With Mitral Valve Surgery

Surgical access to repair or replace the mitral valve. Measured per occurrence.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Mitral Valve Surgery	0 Participants

Secondary

Number of Participants With MR Severity Grade

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 0	0 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 1+	8 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 2+	13 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 3+	7 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 4+	0 Participants

Secondary

Number of Participants With MR Severity Grade

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 0	0 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 1+	14 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 2+	9 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 3+	6 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 4+	0 Participants

Secondary

Number of Participants With MR Severity Grade

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 0	0 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 1+	21 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 2+	5 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 3+	4 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 4+	0 Participants

Secondary

Number of Participants With MR Severity Grade

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 0	0 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 1+	17 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 2+	9 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 3+	4 Participants
AVJ-514	Number of Participants With MR Severity Grade	MR severity grade 4+	0 Participants

Secondary

Number of Participants With NYHA Functional Class

Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With NYHA Functional Class	Class I	18 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class II	8 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class III	2 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class IV	0 Participants

Secondary

Number of Participants With NYHA Functional Class

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With NYHA Functional Class	Class I	19 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class II	8 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class III	2 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class IV	0 Participants

Secondary

Number of Participants With NYHA Functional Class

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With NYHA Functional Class	Class I	21 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class II	8 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class III	1 Participants
AVJ-514	Number of Participants With NYHA Functional Class	Class IV	0 Participants

Secondary

Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery

SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery	1 Participants

Secondary

Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery

SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery	0 Participants

Secondary

Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	29 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not evaluable	1 Participants

Secondary

Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	30 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not evaluable	0 Participants

Secondary

Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	28 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not evaluable	0 Participants

Secondary

Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	30 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not evaluable	0 Participants

Secondary

Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	1 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	28 Participants
AVJ-514	Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not evaluable	0 Participants

Secondary

Number of Participants With the Primary Safety Composite of MAE at 1 Year

MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.

Time frame: 12 months

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With the Primary Safety Composite of MAE at 1 Year	Death	1 Participants
AVJ-514	Number of Participants With the Primary Safety Composite of MAE at 1 Year	Stroke	0 Participants
AVJ-514	Number of Participants With the Primary Safety Composite of MAE at 1 Year	MI	0 Participants
AVJ-514	Number of Participants With the Primary Safety Composite of MAE at 1 Year	Renal failure	1 Participants
AVJ-514	Number of Participants With the Primary Safety Composite of MAE at 1 Year	Non-elective cardiovascular surgery	0 Participants

Secondary

Number of Participants With Usage of Concomitant Cardiac Medications

Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin converting enzyme (ACE) inhibitor	11 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin II receptor blocker	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Aldosterone receptor blocker	2 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Diuretics	27 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Calcium channel blocker	6 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anti-Platelets	16 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anticoagulants	18 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Antiarrhythmics	5 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Cardiac glycosis (Digitalis)	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Statins	17 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other vasodilators	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other cardiac medication	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Beta-blocker	25 Participants

Secondary

Number of Participants With Usage of Concomitant Cardiac Medications

Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin converting enzyme (ACE) inhibitor	12 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin II receptor blocker	5 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Aldosterone receptor blocker	2 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Beta-blocker	25 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Diuretics	27 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Calcium channel blocker	6 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anti-Platelets	15 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anticoagulants	17 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Antiarrhythmics	6 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Cardiac glycosis (Digitalis)	5 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Statins	17 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other vasodilators	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other cardiac medication	4 Participants

Secondary

Number of Participants With Usage of Concomitant Cardiac Medications

Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin converting enzyme (ACE) inhibitor	11 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin II receptor blocker	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Aldosterone receptor blocker	3 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Beta-blocker	25 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Diuretics	29 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Calcium channel blocker	6 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anti-Platelets	16 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anticoagulants	21 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Antiarrhythmics	7 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Cardiac glycosis (Digitalis)	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Statins	17 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other vasodilators	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other cardiac medication	3 Participants

Secondary

Number of Participants With Usage of Concomitant Cardiac Medications

Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin converting enzyme (ACE) inhibitor	11 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Angiotensin II receptor blocker	5 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Aldosterone receptor blocker	3 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Beta-blocker	24 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Diuretics	30 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Calcium channel blocker	9 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anti-Platelets	14 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Anticoagulants	22 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Antiarrhythmics	8 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Cardiac glycosis (Digitalis)	4 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Statins	17 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other vasodilators	9 Participants
AVJ-514	Number of Participants With Usage of Concomitant Cardiac Medications	Other cardiac medication	22 Participants

Secondary

Number of Patients With New York Heart Association (NYHA) Functional Class

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Number of Patients With New York Heart Association (NYHA) Functional Class	Class I	0 Participants
AVJ-514	Number of Patients With New York Heart Association (NYHA) Functional Class	Class II	19 Participants
AVJ-514	Number of Patients With New York Heart Association (NYHA) Functional Class	Class III	10 Participants
AVJ-514	Number of Patients With New York Heart Association (NYHA) Functional Class	Class IV	1 Participants

Secondary

NYHA Functional Class

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	NYHA Functional Class	NYHA I	10 Participants
AVJ-514	NYHA Functional Class	NYHA II	10 Participants
AVJ-514	NYHA Functional Class	NYHA III	0 Participants
AVJ-514	NYHA Functional Class	NYHA IV	1 Participants
AVJ-514	NYHA Functional Class	Not Available	1 Participants

Secondary

NYHA Functional Class

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	NYHA Functional Class	NYHA Class I	16 Participants
AVJ-514	NYHA Functional Class	NYHA Class II	10 Participants
AVJ-514	NYHA Functional Class	NYHA Class III	2 Participants
AVJ-514	NYHA Functional Class	NYHA Class IV	0 Participants

Secondary

NYHA Functional Class

Time frame: 5 years

Secondary

NYHA Functional Class

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	NYHA Functional Class	NYHA Class II	9 Participants
AVJ-514	NYHA Functional Class	NYHA Class III	0 Participants
AVJ-514	NYHA Functional Class	NYHA Class IV	0 Participants
AVJ-514	NYHA Functional Class	NYHA Class I	15 Participants

Secondary

Percentage of Participants With Device Implant Rate

Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.

Time frame: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (NUMBER)
AVJ-514	Percentage of Participants With Device Implant Rate	0	0 percentage of participants
AVJ-514	Percentage of Participants With Device Implant Rate	1	30 percentage of participants
AVJ-514	Percentage of Participants With Device Implant Rate	2	63 percentage of participants
AVJ-514	Percentage of Participants With Device Implant Rate	>=3	7 percentage of participants

Secondary

Percentage of Participants With Discharge Status

Location to which subject was discharged (home or another facility).

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (NUMBER)
AVJ-514	Percentage of Participants With Discharge Status	Released to home	96.7 percentage of participants
AVJ-514	Percentage of Participants With Discharge Status	Released to rehab facility or skilled nursing home	3.3 percentage of participants
AVJ-514	Percentage of Participants With Discharge Status	Returned to rehab facility or skilled nursing home	0 percentage of participants
AVJ-514	Percentage of Participants With Discharge Status	Transferred to another hospital	0 percentage of participants
AVJ-514	Percentage of Participants With Discharge Status	Subject died	0 percentage of participants
AVJ-514	Percentage of Participants With Discharge Status	Other	0 percentage of participants

Secondary

Percentage of Participants With MAE at 1 Year

MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).

Time frame: 1 year

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted. This section talks about MAE at 1 year. A total of two MAES were reported through 1 year. 1 MAE for Death and 1 MAE for Renal Failure.

Arm	Measure	Group	Value (NUMBER)
AVJ-514	Percentage of Participants With MAE at 1 Year	Death	3.3 percentage of participants
AVJ-514	Percentage of Participants With MAE at 1 Year	Stroke	0 percentage of participants
AVJ-514	Percentage of Participants With MAE at 1 Year	Myocardial infarction	0 percentage of participants
AVJ-514	Percentage of Participants With MAE at 1 Year	Renal failure	3.3 percentage of participants
AVJ-514	Percentage of Participants With MAE at 1 Year	Procedure related adverse events	0 percentage of participants

Secondary

Percentage of Participants With Major Adverse Events (MAE) at 30 Days

Time frame: 30 days

Population: Intention-to-Treat (ITT) population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (NUMBER)
AVJ-514	Percentage of Participants With Major Adverse Events (MAE) at 30 Days	Death	0 percentage of participants
AVJ-514	Percentage of Participants With Major Adverse Events (MAE) at 30 Days	Stroke	0 percentage of participants
AVJ-514	Percentage of Participants With Major Adverse Events (MAE) at 30 Days	Myocardial infarction	0 percentage of participants
AVJ-514	Percentage of Participants With Major Adverse Events (MAE) at 30 Days	Renal failure	0 percentage of participants
AVJ-514	Percentage of Participants With Major Adverse Events (MAE) at 30 Days	Procedure related adverse events	0 percentage of participants

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Pulmonary Artery Systolic Pressure (PASP)	35.1 mmHg	Standard Deviation 5.5

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 3 years

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Pulmonary Artery Systolic Pressure (PASP)	35.3 mmHg	Standard Deviation 10.9

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 5 years

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 4 years

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Pulmonary Artery Systolic Pressure (PASP)	40.2 mmHg	Standard Deviation 13

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 24 months

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Pulmonary Artery Systolic Pressure (PASP)	35.4 mmHg	Standard Deviation 8.6

Secondary

Pulmonary Artery Systolic Pressure (PASP)

Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Pulmonary Artery Systolic Pressure (PASP)	37.3 mmHg	Standard Deviation 8.6

Secondary

Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior

Time frame: 1 Year Pre and Post Index Procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (NUMBER)
AVJ-514	Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior	1 year pre index procedure	0.90 Rate of HF Hospitalization
AVJ-514	Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior	1 year post index procedure	0.14 Rate of HF Hospitalization

Secondary

Regurgitant Fraction (RF)

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: 4 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	44.7 percentage of regurgitant fraction	Standard Deviation 22.9

Secondary

Regurgitant Fraction (RF)

Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	23.9 percentage of regurgitant fraction	Standard Deviation 16

Secondary

Regurgitant Fraction (RF)

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	22.9 percentage of regurgitant fraction	Standard Deviation 14.4

Secondary

Regurgitant Fraction (RF)

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	18.7 percentage of regurgitant fraction	Standard Deviation 13.4

Secondary

Regurgitant Fraction (RF)

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	36 percentage of regurgitant fraction	Standard Deviation 16.1

Secondary

Regurgitant Fraction (RF)

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: 2 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	28.6 percentage of regurgitant fraction	Standard Deviation 15

Secondary

Regurgitant Fraction (RF)

Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: 3 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	29.8 percentage of regurgitant fraction	Standard Deviation 18.5

Secondary

Regurgitant Fraction (RF)

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Fraction (RF)	22.2 percentage of regurgitant fraction	Standard Deviation 15.3

Secondary

Regurgitant Volume (RV)

Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	16.9 mL/beat	Standard Deviation 15

Secondary

Regurgitant Volume (RV)

Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	44.0 ml/beat	Standard Deviation 22.6

Secondary

Regurgitant Volume (RV)

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	36.5 ml/beat	Standard Deviation 22.5

Secondary

Regurgitant Volume (RV)

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	27.1 ml/beat	Standard Deviation 18.9

Secondary

Regurgitant Volume (RV)

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	15.1 mL/beat	Standard Deviation 13.6

Secondary

Regurgitant Volume (RV)

Time frame: 5 years

Secondary

Regurgitant Volume (RV)

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	29.5 mL/beat	Standard Deviation 21

Secondary

Regurgitant Volume (RV)

Time frame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	11.4 mL/beat	Standard Deviation 9.5

Secondary

Regurgitant Volume (RV)

Time frame: 30 days

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Regurgitant Volume (RV)	16.9 mL/beat	Standard Deviation 12.3

Secondary

SF-36 QoL Scores

The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for congestive heart failure (CHF) population are 31 & 46, respectively.

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	SF-36 QoL Scores	Physical Component Summary	32.2 units on a scale	Standard Deviation 15.1
AVJ-514	SF-36 QoL Scores	Mental Component Summary	53.0 units on a scale	Standard Deviation 9.3

Secondary

SF-36 QoL Scores

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	SF-36 QoL Scores	Physical Component Summary	36.3 units on a scale	Standard Deviation 15.3
AVJ-514	SF-36 QoL Scores	Mental Component Summary	53.1 units on a scale	Standard Deviation 9.8

Secondary

SF-36 QoL Scores

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	SF-36 QoL Scores	Physical Function (PF)	34.5 score on a scale	Standard Deviation 15.8
AVJ-514	SF-36 QoL Scores	Role Physical (RP)	39.5 score on a scale	Standard Deviation 12.7
AVJ-514	SF-36 QoL Scores	Bodily Pain (BP)	48.8 score on a scale	Standard Deviation 12.7
AVJ-514	SF-36 QoL Scores	General Health (GH)	45.3 score on a scale	Standard Deviation 8.8

Secondary

SF-36 QoL Scores

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	SF-36 QoL Scores	Physical Component Summary	37.6 units on a scale	Standard Deviation 17.1
AVJ-514	SF-36 QoL Scores	Mental Component Summary	53.8 units on a scale	Standard Deviation 8.9

Secondary

SF-36 QoL Scores

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

Time frame: 30 days

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Group	Value (MEAN)	Dispersion
AVJ-514	SF-36 QoL Scores	Physical Component Summary	37.5 units on a scale	Standard Deviation 12.8
AVJ-514	SF-36 QoL Scores	Mental Component Summary	54.9 units on a scale	Standard Deviation 7.6

Secondary

Six Minute Walk Test (6MWT) Distance

The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	324.3 Meters	Standard Deviation 112.7

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	313.7 meters	Standard Deviation 136.7

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: 1 year

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	359.0 meters	Standard Deviation 111.3

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: At baseline (Within 14 days prior to the AVJ-514 procedure)

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	349.4 meters	Standard Deviation 118.4

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: 6 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	338.6 meters	Standard Deviation 106.5

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: 5 years

Secondary

Six Minute Walk Test (6MWT) Distance

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Six Minute Walk Test (6MWT) Distance	336.8 meters	Standard Deviation 119.4

Secondary

Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.

Time frame: 4 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	21 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not Evaluable	1 Participants

Secondary

Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Time frame: 5 years

Secondary

Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.

Time frame: 24 months

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	28 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not Evaluable	0 Participants

Secondary

Systolic Anterior Motion of the Mitral Valve (Present or Absent)

Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.

Time frame: 3 years

Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Yes	0 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	No	24 Participants
AVJ-514	Systolic Anterior Motion of the Mitral Valve (Present or Absent)	Not Evaluable	0 Participants

Secondary

Total Procedure Time

Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.

Time frame: On the day of procedure

Population: ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.

Arm	Measure	Value (MEAN)	Dispersion
AVJ-514	Total Procedure Time	284.6 Minutes	Standard Deviation 90.67

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026

AVJ-514 Japan Trial

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Study design

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Cardiac Index (CI)

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Cardiac Output (CO)

Cardiac Output (CO)

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Cardiac Output (CO)

Cardiac Output (CO)

Cardiac Output (CO)

Cardiac Output (CO)

Cardiac Output (CO)

Cardiac Output (CO)

Change in KCCQ QoL Scores From Baseline to 1 Year

Change in SF-36 QoL Scores From Baseline

Change in SF-36 QoL Scores From Baseline to 1 Year

Changes in Six Minute Walk Test (6MWT) Distance From Baseline

Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year

Device Procedure Time

Device Time

Fluoroscopy Duration

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Forward Stroke Volume (FSV)

Freedom From the Components of the Primary Safety Composite of MAE

Freedom From the Components of the Primary Safety Composite of MAE

Freedom From the Components of the Primary Safety Composite of MAE

Freedom From the Components of the Primary Safety Composite of MAE

Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores

KCCQ QoL Scores

KCCQ QoL Scores

KCCQ QoL Scores

KCCQ QoL Scores

KCCQ QoL Scores

KCCQ QoL Scores

KCCQ QoL Scores

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF)

Left Ventricular Ejection Fraction (LVEF)