NCT06954792

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

Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Regurgitation
• Heart Failure
• Structural Heart Disease
• Interventional Cardiology

Timeline

• Start date: 2027-01-01
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2025-05-02
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States