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

• Conditions: Tricuspid Regurgitation; Heart Failure; Structural Heart Disease; Interventional Cardiology

• Registration Number: NCT06954792
• Lead Sponsor: Columbia University

Brief 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).

Detailed Description

TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® software. Patients with AHI will be compared to a control group without AHI, composed of individuals implanted with TTVR at Columbia University Irving Medical Center. In this substudy at Columbia, the investigators aim to describe AHI incidence, its clinical presentation, its impact on prognosis, and the predictors of its occurrence.

Study Timeline

• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Status Verified: 2025-05
• Study First Posted: 2025-05-02
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Study Start: 2025-06
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality Rate	1 Year	The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Post-procedural Inflammatory Response	Within 48 hours after the procedure	The number of participants with post-procedural inflammatory response will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.
Number of Participants with AHI	Within 24 hours after the procedure	Number of Participants with AHI among all the population screened
Number of Participants with Coronary Artery Disease (CAD)	Baseline (Day 0)	Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.; The number of participants with CAD will be reported.
Number of Participants with Right Ventricular (RV) Dysfunction	Baseline (Day 0)	Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population.; The number of participants with RV dysfunction will be reported.
Number of Participants with Pulmonary Hypertension	Baseline (Day 0)	Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with pulmonary hypertension will be reported.
Number of Participants with Primary Left Ventricular Cardiomyopathy	Baseline (Day 0)	Provide a multimodality description of the AHI population in comparison to the control group by defining the specificities of the AHI population. The number of participants with primary left ventricular cardiomyopathy will be reported.
Number of Participants with Post-Procedural Fever	Within 48 hours after the procedure	The number of participants with post-procedural fever will be reported and used to define the factors associated with the occurrence of AHI after TTVR in multivariable analysis.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States