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Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study

Key facts

Where
New York, United StatesSee the site

Where in United States

  • Columbia University Medical CenterNew York, United StatesNo longer taking part

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Trial details

Who runs it
Columbia University
Trial code
NCT06954792
Record updated
12 February 2026
Original description
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).Read full original descriptionShow less

Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement

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).

Inclusion: 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).

Exclusion: 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.

ClinicalTrials.gov NCT06954792