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

Launched by COLUMBIA UNIVERSITY · Apr 24, 2025

Keywords

ClinConnect Summary

This study, called TTVR-AHI, is a big, sparely funded look at people who had a transcatheter tricuspid valve replacement (TTVR) for severe tricuspid valve problems and heart failure. It collects data from many centers after the procedure to see how often people have acute hemodynamic instability (AHI) within 24 hours, meaning they need medicines to help the heart pump or to raise blood pressure. The researchers will compare those who develop AHI with a control group of similar patients at Columbia University who did not have AHI. The main question is how many patients die within a year and what factors predict outcomes after AHI.

Who can be eligible and what to expect: Adults 18 and older who undergo TTVR, including use of the Evoque valve or other devices under special compassionate use. AHI is defined by needing inotropes (medicines that make the heart pump harder) and/or vasopressors (medicines that raise blood pressure) within 24 hours after the procedure due to unstable blood flow. People are excluded if there was a major complication during the procedure explaining the instability (like heavy bleeding or heart tear) or if inotropes/vasopressors were started routinely after the procedure without signs of poor blood flow. This is an observational registry using routine medical data, with an estimated 140 participants, and results will help describe how often AHI occurs, how it looks clinically, and what factors predict it. The study is currently enrolling by invitation at Columbia University, not a drug or device trial, and data sharing is not yet decided; the project is expected to be completed around May 2026.

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Eligibility criteria

• 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.