Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study (TTVR-AHI)

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure; Structural Heart Disease; Tricuspid Regurgitation; Interventional Cardiology

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 Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population represents TTVR patients presenting specifically an AHI after their intervention. In turn, the control group includes an all-comer population undergoing TTVR.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No AHI; Patients undergoing TTVR without presenting any AHI post-procedurally
AHI; Patients undergoing TTVR and presenting AHI within 24h after the procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Coronary Artery Disease (CAD)	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.	Baseline (Day 0)
Number of Participants with Right Ventricular (RV) Dysfunction	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.	Baseline (Day 0)
Number of Participants with Pulmonary Hypertension	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.	Baseline (Day 0)
Number of Participants with Primary Left Ventricular Cardiomyopathy	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.	Baseline (Day 0)
Number of Participants with Post-Procedural Fever	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.	Within 48 hours after the procedure
Number of Participants with Post-procedural Inflammatory Response	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.	Within 48 hours after the procedure
Number of Participants with AHI	Number of Participants with AHI among all the population screened	Within 24 hours after the procedure

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Tamim Nazif, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Valve Insufficiency
• Other Study ID Numbers: AAAV0931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No