2019-06 TRISCEND Study
Purpose
Early feasibility 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 - The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Exclusion Criteria
- Unsuitable anatomy - Previous tricuspid valve repair or replacement - Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Treatment |
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System |
|
Recruiting Locations
University of Maryland
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
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