Print

Purpose

Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Conditions

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

Recruiting Locations

University of Maryland
Baltimore, Maryland 21201
Contact:
Freshta Akbari
410-328-4562
fakbari@som.umaryland.edu

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.