Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
Mitral Valve Regurgitation, MitraClip, MitraClip NT, Japan MitraClip NT Postmarketing Surveillance
Brief summary
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Detailed description
This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance. Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.
Interventions
DEVICEMitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System
Sponsors
Abbott
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Refer to MitraClip IFU
Exclusion criteria
Refer to MitraClip IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Leaflet Device Attachment (SLDA) Rate | up to 30 Days | SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device |
| No of Participants With Acute Procedural Success (APS) | up to 7 days (Discharge visit) from Procedure date | APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. 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+). |
Countries
Japan
Participant flow
Recruitment details
A total of 500 subjects were enrolled at 40 sites April 2, 2018 to March 31, 2020.
Participants by arm
| Arm | Count |
|---|---|
| MitraClip NT System Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System | 500 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 163 |
| Overall Study | Lost to Follow-up | 75 |
| Overall Study | Termination Reasons | 3 |
Baseline characteristics
| Characteristic | MitraClip NT System |
|---|---|
| Age, Continuous | 77.92 Years STANDARD_DEVIATION 9.48 |
| Baseline Effective Regurgitant Orifice Area | 0.40 cm^2 STANDARD_DEVIATION 0.26 |
| Baseline Etiology of Mitral Regurgitation Degenerative MR Only | 126 Participants |
| Baseline Etiology of Mitral Regurgitation Functional MR Only | 358 Participants |
| Baseline Etiology of Mitral Regurgitation Mixed | 16 Participants |
| Body Mass Index | 21.01 Kg/m^2 STANDARD_DEVIATION 3.22 |
| Brain Natriuretic Peptide (BNP) | 567.11 pg/mL STANDARD_DEVIATION 766.67 |
| Cardiac Intervention History CRT/CRT-D | 86 Participants |
| Cardiac Intervention History Percutaneous Coronary Interventions | 142 Participants |
| Cardiac Intervention History Prior Cardiac Surgeries | 89 Participants |
| Cardiovascular History Atrial Fibrillation | 316 Participants |
| Cardiovascular History Cardiac Arrhythmia | 358 Participants |
| Cardiovascular History Dyslipidemia | 216 Participants |
| Cardiovascular History Hypertension | 300 Participants |
| Cardiovascular History Prior Cerebrovascular Accident (CVA) | 89 Participants |
| Cardiovascular History Prior Myocardial Infarction | 124 Participants |
| Cardiovascular History Prior Transient Ischemic Attack (TIA) | 13 Participants |
| Co-Morbidity Cancer | 66 Participants |
| Co-Morbidity Chronic Lung Diesase | 77 Participants |
| Co-Morbidity Cirrhosis | 6 Participants |
| Co-Morbidity Currently Smoking | 30 Participants |
| Co-Morbidity Diabetes | 144 Participants |
| Co-Morbidity Peripheral Artery Disease | 56 Participants |
| Co-Morbidity Prior Major Bleeding | 13 Participants |
| Co-Morbidity Renal Failure | 244 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 500 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Heart Valve Intervention | 28 Participants |
| Height | 156.96 Centimeters STANDARD_DEVIATION 10.02 |
| Left Ventricular Ejection Fraction (LVEF) | 46.10 Percentage Of Ejection Fraction STANDARD_DEVIATION 14.93 |
| Left Ventricular End Diastolic Volume (LVEDV) | 160.26 mL STANDARD_DEVIATION 75.31 |
| Left Ventricular End Systolic Volume (LVESV) | 93.54 mL STANDARD_DEVIATION 64.43 |
| N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | 6808.17 Pg/mL STANDARD_DEVIATION 17329.44 |
| Prior Heart Failure Hospitalization Within 1 year | 321 Participants |
| Region of Enrollment Japan | 500 participants |
| Regurgitant Volume | 58.04 mL/beat STANDARD_DEVIATION 27.61 |
| Serum Creatinine | 1.71 mg/dl STANDARD_DEVIATION 1.54 |
| Sex: Female, Male Female | 206 Participants |
| Sex: Female, Male Male | 294 Participants |
| Society of Thoracic Surgeons (STS) Score | 11.95 Percentage of Expected Mortality STANDARD_DEVIATION 9.66 |
| Weight | 52.05 Kilograms STANDARD_DEVIATION 10.68 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 163 / 500 |
| other Total, other adverse events | 25 / 500 |
| serious Total, serious adverse events | 322 / 500 |
Outcome results
Primary
No of Participants With Acute Procedural Success (APS)
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. 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: up to 7 days (Discharge visit) from Procedure date
Population: All subjects with available data were used for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip NT System | No of Participants With Acute Procedural Success (APS) | 452 Participants |
Primary
Single Leaflet Device Attachment (SLDA) Rate
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Time frame: up to 30 Days
Population: All subjects with available data were included for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip NT System | Single Leaflet Device Attachment (SLDA) Rate | 1.21 percentage of SLDAs |