NCT06954792Enrolling by invitation
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 24 Apr 2025
- Start date
- 1 Jan 2027
- Primary completion date
- 1 May 2029
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT06954792
What you commit to
- Study type: Observational
- Planned participants: 140
- From 1 Jan 2027 to the primary completion date, 1 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
Other
- Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
Who the study is looking for
- Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And
- Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.