Early Feasibility Study of the Cardiac Implants Percutaneous Ring Annuloplasty System

This is an early-stage study testing a new minimally invasive device for people with a leaky tricuspid valve — the valve on the right side of the heart. The device is inserted through a vein in the neck (not through open-heart surgery) to tighten the valve ring and reduce the leak. The study is for people who have tried medications but still have significant right-sided heart failure symptoms. You may be eligible if: • You are 18 years of age or older • You have moderate to severe tricuspid valve regurgitation (a leaky tricuspid valve) • You have symptoms of right heart failure despite being on optimal medication • A team of heart specialists has agreed that this type of procedure is appropriate for you • Your heart's pumping function (LVEF) is at least 30% You may NOT be eligible if: • You had an acute heart failure hospitalization within 4 weeks • Your tricuspid valve problem is due to a structural or congenital cause (not functional) • You have had a prior tricuspid repair or replacement • You have a blood clot or growth inside your heart • You have severe right ventricular dysfunction • You have recently had a heart attack, stroke, or coronary procedure • You are pregnant or breastfeeding • You have a pacemaker lead through the tricuspid valve that cannot be moved Talk to your doctor to see if this trial is right for you.