2019-06 TRISCEND Study

Purpose

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Conditions

  • Tricuspid Valve Regurgitation
  • Heart Valve Diseases
  • Cardiovascular Diseases

Eligibility

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

Inclusion Criteria

  • Functional or degenerative TR moderate or greater - Symptomatic despite medical therapy or prior HF hospitalization from TR - The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

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 in which the patient has not reached a primary endpoint

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
  • Device: Transcatheter Tricuspid Valve Replacement
    Replacement of the tricuspid valve through a transcatheter approach
    Other names:
    • Edwards EVOQUE Tricuspid Valve Replacement System

More Details

Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

TMTT Clinical
949-250-2500
TMTT_Clinical@Edwards.com

Detailed Description

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.