Clinical trial

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

NCT04482062

Name

2020-05

Description

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

Trial arms

Trial start

2021-04-09

Estimated PCD

2024-06-30

Trial end

2029-12-31

Status

Recruiting

Treatment

Edwards EVOQUE System

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT

Arms:

Continued Access Study, Edwards EVOQUE System & OMT, Single-Arm Registry

Other names:

Transcatheter tricuspid valve replacement

Optimal Medical Therapy

Arms:

Optimal Medical Therapy (OMT)

Size

1070

Primary endpoint

TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement

6 months

Rate of Major Adverse Events (MAE)

30 days

Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement

1 year

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1070, 'type': 'ESTIMATED'}}

Updated at

2024-01-16

1 organization

1 product

6 indications

Organization

Edwards Lifesciences

Product

Optimal Medical Therapy

Indication

Tricuspid Regurgitation

Indication