Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT06954792
- Status
- Enrolling By Invitation
Conditions
- Heart Failure
- Interventional Cardiology
- Structural Heart Disease
- Tricuspid Regurgitation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefore treated with transcatheter tricuspid valve replacement (TTVR) devices. This substudy of the main registry will focus on those with post-procedural acute hemodynamic instability (AHI).
Key Dates
- Start date
- Jan 31, 2027
- Status verified
- Feb 2026
- Primary completion
- May 1, 2029
- Completion
- May 1, 2029
Study Design
- Enrollment
- 140 participants (estimated)
Arms
- Arm: No AHIPatients undergoing TTVR without presenting any AHI post-procedurally
- Arm: AHIPatients undergoing TTVR and presenting AHI within 24h after the procedure
Primary Outcome Measure
Mortality Rate [ Time Frame: 1 Year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | - |
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