By InvitationNot Applicable

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

United States140 participantsStarted 2027-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Mortality Rate

Timeframe: 1 Year

Trial details

NCT IDNCT06954792

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-05-01

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