Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Eligibility

Primary outcome measure(s)

• Tricuspid regurgitation grade — Up to 7 days, 30 days, and 1 year
  Number of patients with optimal TR grade (≤1 on a 0-5 grade scale)
• Number of patients with major adverse events (MAE rates) — 30 days
  The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Trial sites (23)