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

Inclusion Criteria:

• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspidregurgitation;

• ≥18 and ≤85 years old;

• NYHA II, III, or ambulatory IV;

• Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient ondiuretic 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 indexprocedure;

• Chronic oral steroid use (≥6 months);

• Life expectancy of less than 12-months