Clinical trial NCT06954792: Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Official title: Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tricuspid Regurgitation
Heart Failure
Structural Heart Disease
Interventional Cardiology
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Mortality Rate
timeFrame: 1 Year
Secondary outcomes:
measure: Number of Participants with Coronary Artery Disease (CAD)
timeFrame: Baseline (Day 0)
measure: Number of Participants with Right Ventricular (RV) Dysfunction
timeFrame: Baseline (Day 0)
measure: Number of Participants with Pulmonary Hypertension
timeFrame: Baseline (Day 0)
measure: Number of Participants with Primary Left Ventricular Cardiomyopathy
timeFrame: Baseline (Day 0)
measure: Number of Participants with Post-Procedural Fever
timeFrame: Within 48 hours after the procedure
measure: Number of Participants with Post-procedural Inflammatory Response
timeFrame: Within 48 hours after the procedure
measure: Number of Participants with AHI
timeFrame: Within 24 hours after the procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Tamim Nazif, MD
role: PRINCIPAL_INVESTIGATOR
References: