Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- Boston Biomedical Associates
- Locations
- 3
- Primary Endpoint
- 1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
This study is to evaluate the safety and technical performance of the Cardiovalve Transfemoral System for tricuspid valve replacement. Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.
Detailed Description
The Cardiovalve Transfemoral System for tricuspid valve replacement Data collected in the clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is 85 ≥ Age ≥ 18 years
- •Participant has severe, symptomatic tricuspid regurgitation (TR) ≥ 3+ based upon echocardiography, as assessed by Independent core laboratory
- •Participant is New York Heart Association (NYHA) Class II-IVa
- •Participant has left ventricular ejection fraction (LVEF) ≥ 35%
- •Participant distance of 6 minute walk test (6MWT) ≥ 60 m
- •Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation and Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
- •Acceptable by the site "Heart Team" including an interventional cardiologist, cardiothoracic surgeon, heart failure cardiologist and recommended as a candidate for the Cardiovalve System
- •Participant approved by the Subject Screening Committee
Exclusion Criteria
- •Known significant intracardiac shunt (e.g. septal defect) or congenital structural heart disease (PFO's without significant shunts are allowed)
- •Significant coronary artery disease requiring treatment
- •Primary tricuspid disease (e.g. rheumatic, myxomatous degeneration, tricuspid valve prolapse)
- •Severe right ventricular failure per ASE guidelines1
- •Systolic pulmonary arterial pressure \> 65 mmHg as assessed by transthoracic echocardiography
- •Presence of any known life threatening non-cardiac disease that will limit the subject's life expectancy to less than one year
- •Cerebrovascular event (stroke, TIA) within the past 3 months
- •Active endocarditis or history of mitral/tricuspid endocarditis within the last 12 months
- •Patient has significant left sided valvular heart disease which requires treatment (e.g. mitral regurgitation or stenosis, and aortic regurgitation or stenosis)
- •Documented primary coagulopathy or platelet disorder, including thrombocytopenia (absolute platelet count \<90k)
Outcomes
Primary Outcomes
1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant
Time Frame: 30 Days
Cardiovalve Technical Success defined as: I Successful access, delivery and retrieval of the delivery system; II Successful deployment of correct positioning of the first intended implant; III Freedom from emergency surgery or reintervention related to the device or access procedure without any procedural mortality, stroke, and device dysfunction at 30-day follow-up.
Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline
Time Frame: 30 Days
Cardiovalve Clinical Performance will be evaluated as: I The reduction in degree of tricuspid regurgitation measured immediately after the procedure compared to baseline; II The reduction in degree of tricuspid regurgitation measured at the time of discharge or 7 days post procedure, whichever comes first, in comparison with baseline Tricuspid Regurgitation is measured using Echocardiography and is graded based on degree of severity using grading conventions from 0 to 4+. 0 = absent 1. = mild 2. = moderate 3. = moderate to severe 4. = severe
Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days
Time Frame: 30 Days
The ability of the Cardiovalve to be implanted without Major Device Related Adverse Events through thirty (30) days including: I Death (Cardiovascular mortality vs non-cardiovascular); II Reintervention (operative or transcatheter) due to progressive or recurrent TR or device related complications; III Disabling stroke; IV Myocardial infarction (MVARC definition); V Major access site and vascular complications; VI Fatal or life-threatening bleeding (MVARC Type III-V); VII Arrhythmia and conduction disorder requiring permanent pacing; VIII Right coronary artery occlusion requiring intervention; IX Cardiac tamponade, X Renal failure requiring dialysis
Secondary Outcomes
- Secondary Performance Endpoint - 6 minute walk test(30 days, 3 months, 6 months)
- Secondary Performance Endpoint - Kansas City Cardiomyopathy Questionnaire(30 days, 3 months, 6 months)
- Secondary Performance Endpoint - Tricuspid Regurgitation Severity(30 days, 3 months, 6 months)
- Secondary Performance Endpoint - Cusp Insufficiency(30 days, 3 months, 6 months)
- Secondary Performance Endpoint - Unrestricted Movement of Cusps(30 days, 3 months, 6 months)
- Secondary Performance Endpoint - New York Heart Association (NYHA) functional class(30 days, 3 months, 6 months)