The SCOUT Study - Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

To assess the early safety and performance of the Percutaneous Tricuspid Valve Annuloplasty System (PTVAS), also referred to as Trialign™, for the treatment of symptomatic chronic functional tricuspid regurgitation in patients with a minimum of moderate tricuspid regurgitation and for whom left-sided valve surgery is not planned.

Heart & Vascular - Structural Heart Trials, Heart & Vascular
Sameer Gafoor, MD
Andrea Drouhard

General 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) and ≤55 mm (or 29 mm/m2)

General 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

Andrea Drouhard