Clinical study

Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch™ System (PREVENT)

PREVENT TriCinch™ European FIH Trial

Prospective, single arm multi-center, study to evaluate the safety and performance of TriCinch
System for functional Tricuspid Regurgitation (TR) repair

Functional TR 24 patients Endpoints : Safety, Performance, Quality of Life

 

Key Inclusion Criteria

  • Functional symptomatic Moderate to Severe TR
  • Heart team evidence (anatomical and clinical approval)
  • Severe dilatation of the tricuspid annulus (>40 mm)

 

Endpoints

Primary

  • Acute safety at 30 days
  • Acute device delivery success.
  • Ability to reduce TR

Secondary

  • Safety at 3 and 6 months
  • Quality of life assessment
  • No worsening of TR with respect to Baseline

 

PREVENT Feasibility Trial → Enrollment complete