Aortic Insufficiency, Aortic Stenosis, Aortic Valve Failure, Aortic Valve Stenosis
Conditions
Brief summary
The objective of this data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Detailed description
Two options currently exist to treat failed surgical aortic bioprostheses: transcatheter valve-in-valve implantation (ViV) or redo surgical aortic valve replacement (rAVR). The objective of this comprehensive data-collection study is to retrospectively evaluate the safety and clinical performance of the Portico transthoracic aortic valve for Valve-in-Valve treatment of a failed aortic surgical bioprosthetic valve in patients who are considered at increased surgical risk for a redo surgical aortic valve replacement.
Interventions
DEVICETranscatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject had a degenerated surgical aortic bioprosthetic valve with severe aortic stenosis, severe regurgitation, or a combination of at least moderate stenosis with at least moderate regurgitation per EAPCI-ESC-EACTS standardized criteria. 2. Surgical bioprosthesis true inner diameter (true ID) was ≥ 19 mm and ≤ 27 mm and was confirmed by either CT or confirmed by the Valve in Valve Aortic App. Refer to the PCR website https://www.pcronline.com/PCR-Publications/PCR-mobile-apps/Valve-in-Valve-Aortic-app Note: if CT was contraindicated and/or not possible to be obtained, a transesophageal echocardiogram (TEE) will be accepted for sizing. 3. Prior to Portico ViV procedure, the patient was deemed at increased risk for surgery to replace the surgical aortic bioprosthetic valve. 4. Subject provided written informed consent prior to performing data collection for study specific visits. For patients that are deceased at the time of enrollment, all institutional/local legal and regulatory requirements for consent must be met prior to enrollment and data collection. 5. Subject is ≥ 18 years of age or legal age in host country at the time of consent. 6. Prior to the Portico ViV index procedure, the subject had New York Heart Association (NYHA) class II, III, or IV. 7. Subject had a minimum vessel diameter of 6.0 mm for Portico™ delivery system access or a minimum of 5.0 mm for the FlexNav™ delivery system. 8. Subject had the Portico or FlexNav delivery system enter their vasculature
Exclusion criteria
1. Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure (MI defined as: ST Segment Elevation as evidenced on 12 Lead ECG). 2. Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC\<3,000 mm3), acute anemia (Hb \<9 g/dL), or thrombocytopenia (platelet count \<50,000 cells/mm³). 3. Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance) 4. Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram. 5. Subject had imaging evidence of intracardiac mass, thrombus or vegetation. 6. Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure. 7. Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure. 8. Subject had renal insufficiency (serum creatinine \>3.0 mg/dL (265.5μmol/L)) and/or end stage renal disease requiring chronic dialysis. 9. Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure. 10. Surgical aortic bioprosthetic valve was unstable or rocking. 11. Subject had a vascular condition (i.e. stenosis, tortuosity, or severe calcification) that made insertion and endovascular access to the aortic valve impossible. 12. Subject was unable to tolerate antiplatelet or anticoagulant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. | 30 days post index procedure | Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications |
| Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. | 1 year post index procedure | Composite of all-cause mortality or disabling stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Clinical Benefit Endpoint - NYHA Class | 30 days post index procedure | Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications. |
| Paravalvular Leak as Measured by Core Lab Echocardiography | 30 Days | Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe. |
| Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 30 days | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. |
| Number of Participants With Procedural Success | Procedure | Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system |
| Aortic Valve Area Measured by Core Lab Echocardiography | 3 Years | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. |
| New Pacemaker Implant | 30 days | New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker. |
| Aortic Valve Area as Measured by Core Lab Echocardiography | 30 days | Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment. |
| Evaluation of Adverse Event Rates (Descriptive Endpoint) | 30 days post index procedure | All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis. |
Countries
Australia, Denmark, Germany, United Kingdom
Participant flow
Recruitment details
A total 6 clinical sites from four countries enrolled a total of 71 subjects between October, 2021 and September, 2023. Subjects were enrolled to two cohorts: the Primary Cohort enrolled subjects with a surgical bioprosthesis true inner diameter (ID) between 19 mm and 27 mm, while the Exploratory Cohort enrolled subjects with a true ID outside that range. Once enrolled, subjects completed follow up visits at 30 days, 1-year, and annually through five years.
Participants by arm
| Arm | Count |
|---|---|
| Primary Analysis Population The primary analysis population will include patients who have signed an Informed Consent Form, and at minimum, the Portico delivery system entered his/her vasculature for an attempted Portico ViV implant. Patients must have met the sizing requirements of the PorticoTM transthoracic aortic valve sizing specification (≥19 mm and ≤27 mm).
Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement | 57 |
| Exploratory Registry Arm The exploratory registry arm will collect data for patients that were treated for a failed surgical bioprosthetic aortic valve true inner diameter size of \<19 mm or \>27 mm.
Transcatheter Aortic Valve Replacement: Transcatheter Aortic Valve Replacement for the treatment of a failed surgical aortic valve bioprosthesis, Valve-in-Valve (ViV), in patients who were considered to be at increased risk for redo surgical aortic valve replacement | 14 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 25 | 7 |
| Overall Study | Withdrawal by Subject | 9 | 0 |
Baseline characteristics
| Characteristic | Primary Analysis Population | Exploratory Registry Arm | Total |
|---|---|---|---|
| Age, Continuous | 79.7 years STANDARD_DEVIATION 6.2 | 80.6 years STANDARD_DEVIATION 9.3 | 79.9 years STANDARD_DEVIATION 0 |
| Ejection Fraction | 56.1 percent (%) STANDARD_DEVIATION 10.2 | 59.5 percent (%) STANDARD_DEVIATION 9.9 | 56.7 percent (%) STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 14 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 46 Participants | 6 Participants | 52 Participants |
| Race (NIH/OMB) White | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Female | 16 Participants | 11 Participants | 27 Participants |
| Sex: Female, Male Male | 41 Participants | 3 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 57 | 2 / 14 |
| other Total, other adverse events | 41 / 57 | 7 / 14 |
| serious Total, serious adverse events | 44 / 57 | 10 / 14 |
Outcome results
Primary
Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke.
Composite of all-cause mortality or disabling stroke.
Time frame: 1 year post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Analysis Population | Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. | 7 Participants |
| Exploratory Registry Arm | Primary Performance Endpoint: Rate of All-cause Mortality or Disabling Stroke. | 0 Participants |
Primary
Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication.
Composite of all-cause mortality, disabling stroke, life threatening bleeding requiring blood transfusion, acute kidney injury (AKI) requiring dialysis, and major vascular complications
Time frame: 30 days post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Analysis Population | Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. | 2 Participants |
| Exploratory Registry Arm | Primary Safety Endpoint: The Rate of All-cause Mortality, Disabling Stroke, Life-threatening Bleeding Requiring Blood Transfusion, Acute Kidney Injury (AKI) Requiring Dialysis, and Major Vascular Complication. | 0 Participants |
Secondary
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 1 Year
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.41 cm^2 | Standard Deviation 0.32 |
| Exploratory Registry Arm | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.82 cm^2 | Standard Deviation 0.56 |
Secondary
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 30 days
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.47 cm^2 | Standard Deviation 0.36 |
| Exploratory Registry Arm | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.25 cm^2 | Standard Deviation 0.25 |
Secondary
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 5 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Aortic Valve Area as Measured by Core Lab Echocardiography | 2.09 cm^2 | — |
| Exploratory Registry Arm | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.26 cm^2 | Standard Deviation 0.34 |
Secondary
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 4 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exploratory Registry Arm | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.72 cm^2 | Standard Deviation 0.4 |
Secondary
Aortic Valve Area as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 2 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.47 cm^2 | Standard Deviation 0.58 |
| Exploratory Registry Arm | Aortic Valve Area as Measured by Core Lab Echocardiography | 1.33 cm^2 | Standard Deviation 0.12 |
Secondary
Aortic Valve Area Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 3 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Aortic Valve Area Measured by Core Lab Echocardiography | 1.63 cm^2 | Standard Deviation 0.2 |
| Exploratory Registry Arm | Aortic Valve Area Measured by Core Lab Echocardiography | 1.48 cm^2 | Standard Deviation 0.37 |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 5 years post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 100.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 0.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 0.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 100.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 0.0 percent |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 4 years post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 75.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 25.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 100 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 0.0 percent |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 2 years post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 61.9 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 28.6 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 9.5 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 50.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 50.0 percent |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 30 days post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 69.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 24.1 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 6.9 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 50.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 12.5 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 37.5 percent |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 3 years post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 60.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 10.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 30.0 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 66.7 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 33.3 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 0.0 percent |
Secondary
Assessment of Clinical Benefit Endpoint - NYHA Class
Change in New York Heart Association (NYHA) functional classification from baseline to 30 days, 1 year, and annually through 5 years. The New York Heart Association (NYHA) functional classification is a system used to categorize the severity of heart failure based on the patient's symptoms and functional capacity. NYHA Functional Classification Class I (No Limitation): Class II (Mild Limitation): Class III (Moderate Limitation): Class IV (Severe Limitation): Class I and II are associated with better functional status and quality of life, indicating less severe heart failure. Worse Outcomes: Class III and IV represent more severe heart failure, with significant limitations and increased risk of complications.
Time frame: 1 year post index procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 54.5 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 40.9 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 4.5 percent |
| Primary Analysis Population | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class IV | 0.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class I | 40.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class III | 20.0 percent |
| Exploratory Registry Arm | Assessment of Clinical Benefit Endpoint - NYHA Class | Class II | 40.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 3 years post index procedure
Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 13.6 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 1.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 24.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 15.6 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 5 years post index procedure
Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 45.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 19.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 1.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 15.6 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Minor, Major, and life-threatening bleeding, major vascular complication, access-related non-vascular complication, or cardiac structure complication, acute kidney injury (AKI) stages 1-4, Endocarditis, Clinically significant valve thrombosis.
Time frame: 30 days post index procedure
Population: All values provided have been rounded to the nearest tenth decimal place.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 3 AKI | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 4 AKI | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 1 Bleeding | 5.3 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 2 Bleeding | 5.3 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 3 Bleeding | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 4 Bleeding | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major Vascular Complication | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 1 AKI | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major access-related non-vascular complication | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major cardiac structure complication | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 2 AKI | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Myocardial infarction | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Coronary obstruction | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 1.8 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Coronary obstruction | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 1 AKI | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 2 AKI | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 3 AKI | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stage 4 AKI | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 1 Bleeding | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 2 Bleeding | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 3 Bleeding | 21.4 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Type 4 Bleeding | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major Vascular Complication | 21.4 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major access-related non-vascular complication | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Major cardiac structure complication | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Myocardial infarction | 0.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), Transient Ischemic Attacks (TIA), Myocardial infarction (MI), Coronary obstruction, Endocarditis, Clinically significant valve thrombosis.
Time frame: 1 year post index procedure
Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 1.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 7.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Myocardial infarction | 1.9 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Coronary obstruction | 4.2 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 10.5 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Coronary obstruction | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Myocardial infarction | 0.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 2 years post index procedure
Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 9.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 1.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 12.4 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 15.6 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
Secondary
Evaluation of Adverse Event Rates (Descriptive Endpoint)
All-cause mortality, Cardiovascular-related mortality, All Stroke (by severity), TIA
Time frame: 4 years post index procedure
Population: Event rates for 1-year follow up and beyond are presented as Kaplan-Meier rates and may not correspond to whole numbers of patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 19.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 1.1 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 3.5 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 1.8 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Primary Analysis Population | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 38.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Clinically significant valve thrombosis | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All-cause mortality | 15.6 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Cardiovascular Mortality | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | All stroke | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Fatal stroke | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke with disability | 7.1 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Stroke without disability | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | TIA | 0.0 percent |
| Exploratory Registry Arm | Evaluation of Adverse Event Rates (Descriptive Endpoint) | Endocarditis | 0.0 percent |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 4 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 19.90 mmHg | — |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 6.50 mmHg | Standard Deviation 1.84 |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 30 days
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 13.90 mmHg | Standard Deviation 5.66 |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 14.67 mmHg | Standard Deviation 4.82 |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 1 year
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 11.13 mmHg | Standard Deviation 5.18 |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 8.40 mmHg | Standard Deviation 3.58 |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 2 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 13.49 mmHg | Standard Deviation 6.85 |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 11.17 mmHg | Standard Deviation 7.02 |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 3 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 12.00 mmHg | Standard Deviation 4.78 |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 9.05 mmHg | Standard Deviation 4.59 |
Secondary
Mean Transvalvular Gradient as Measured by Core Lab Echocardiography
Echocardiographic examinations were forwarded to the independent echocardiographic core lab MedStar Health Echocardiography Core Laboratory for interpretation. It was the responsibility of each study site to perform the local interpretation of the echocardiogram for clinical assessment.
Time frame: 5 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Analysis Population | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 9.15 mmHg | Standard Deviation 2.19 |
| Exploratory Registry Arm | Mean Transvalvular Gradient as Measured by Core Lab Echocardiography | 14.00 mmHg | Standard Deviation 10.75 |
Secondary
New Pacemaker Implant
New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
Time frame: 1 year
Population: Pacemaker implant (PPI) is unique and only applies to a portion of the patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Population | New Pacemaker Implant | 1.8 percent |
| Exploratory Registry Arm | New Pacemaker Implant | 0.0 percent |
Secondary
New Pacemaker Implant
New permanent pacemaker implantation(PPI), with precision of the indication and the number of days postimplant of the placement of the new permanent pacemaker.
Time frame: 30 days
Population: Pacemaker implant (PPI) is unique and only applies to a portion of the patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Analysis Population | New Pacemaker Implant | 4.2 percent |
| Exploratory Registry Arm | New Pacemaker Implant | 0.0 percent |
Secondary
Number of Participants With Procedural Success
Defined as absence of procedural mortality AND successful access, delivery of the valve, and retrieval of the delivery system
Time frame: Procedure
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Analysis Population | Number of Participants With Procedural Success | 53 Participants |
| Exploratory Registry Arm | Number of Participants With Procedural Success | 12 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 3 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 1 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 2 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 1 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 2 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 2 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 2 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 4 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 1 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 30 Days
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 10 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 5 Years
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 1 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 1 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |
Secondary
Paravalvular Leak as Measured by Core Lab Echocardiography
Paravalvular leak severity was categorized based on echocardiographic criteria, including the size and hemodynamic impact of the leak, as determined by the core lab assessment and categorized under 4 grades: none/trace/trivial; mild; moderate and severe.
Time frame: 1 Year
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 5 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 1 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Primary Analysis Population | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Severe | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | None/trace/trivial | 2 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Moderate | 0 Participants |
| Exploratory Registry Arm | Paravalvular Leak as Measured by Core Lab Echocardiography | Mild | 0 Participants |