TRISCEND II Pivotal Trial

Purpose

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Conditions

  • Tricuspid Valve Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease
  • Heart Valve Diseases
  • Cardiovascular Diseases
  • Heart Failure

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy - TR graded as severe or greater - Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria

  • Tricuspid valve anatomic contraindications - Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months - Hemodynamic instability - Refractory heart failure requiring advanced intervention - Currently participating in another investigational study

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Edwards EVOQUE System & OMT 		Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
  • Device: Edwards EVOQUE System
    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
    Other names:
    • Transcatheter tricuspid valve replacement
Active Comparator
Optimal Medical Therapy (OMT) 		Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
  • Drug: Optimal Medical Therapy
    Optimal Medical Therapy
Experimental
Single-Arm Registry 		Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
  • Device: Edwards EVOQUE System
    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
    Other names:
    • Transcatheter tricuspid valve replacement
Experimental
Continued Access Study 		Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.
  • Device: Edwards EVOQUE System
    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
    Other names:
    • Transcatheter tricuspid valve replacement

More Details

Status
Active, not recruiting
Sponsor
Edwards Lifesciences

Study Contact

Detailed Description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.