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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Edwards Lifesciences
Study Contact
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.