Tricuspid RegurgitationHeart and circulation
What this study is
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).
Study details
- Official title
- Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
- Sponsor
- Columbia University
- Conditions
- Tricuspid Regurgitation · Heart Failure · Structural Heart Disease · Interventional Cardiology
- Enrolling
- 140 people
- Starts
- 2026-01
- Est. completion
- 2026-05-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
You can't join if
- Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openColumbia University Medical Center
New York, New York, United States
Study team
Sponsor
Columbia University
Study ID AAAV0931
Principal investigator
Tamim Nazif, MD
Columbia University
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.