Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic
functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The
study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be
conducted through 2-years post implantation.

Inclusion Criteria:

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

- ≥18 and ≤85 years old;

- NYHA II - IV;

- Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on
diuretic use;

- LVEF ≥35%

- Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29
mm/m2 (Superscript))

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