Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 5:10 PM
Study NCT ID:
NCT06954792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-12
First Post:
2025-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTVR-AHI
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: