Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation (NCT04100720) | Clinical Trial Compass
WithdrawnNot Applicable
Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation
Stopped: COVID Impact
United States0Started 2024-02
Plain-language 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.
Who can participate
Age range18 Years – 84 Years
SexALL
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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)
1. Primary Performance Endpoint - Technical Success of Cardiovalve Delivery and Function in each participant
Timeframe: 30 Days
2
Primary Performance Endpoint - Clinical Performance - Reduction in Tricuspid Regurgitation severity measured using Echocardiography and compared to baseline
Timeframe: 30 Days
3
Primary Safety Endpoint (Patient Based) Participants Implanted without Major Device Related Adverse Events through thirty days