Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Inclusion Criteria:

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
• ≥18 and ≤85 years old;
• NYHA II, III, or ambulatory IV;
• Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
• patient is at high risk for open heart valve surgery
• LVEF ≥35%
• Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2)

Exclusion Criteria:

• Pregnant or lactating female;
• Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
• Previous tricuspid valve repair or replacement;
• Severe coronary artery disease;
• MI or known unstable angina within the 30-days prior to the index procedure;
• Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
• Chronic oral steroid use (≥6 months);
• Life expectancy of less than 12-months