Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Heart Failure, Structural Heart Disease, Interventional Cardiology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement
Overview
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.
Primary outcome measures
- Mortality Rate [Time frame: 1 Year]
Secondary outcome measures (7)
- Number of Participants with Coronary Artery Disease (CAD) [Time frame: Baseline (Day 0)]
- Number of Participants with Right Ventricular (RV) Dysfunction [Time frame: Baseline (Day 0)]
- Number of Participants with Pulmonary Hypertension [Time frame: Baseline (Day 0)]
- Number of Participants with Primary Left Ventricular Cardiomyopathy [Time frame: Baseline (Day 0)]
- Number of Participants with Post-Procedural Fever [Time frame: Within 48 hours after the procedure]
- Number of Participants with Post-procedural Inflammatory Response [Time frame: Within 48 hours after the procedure]
- Number of Participants with AHI [Time frame: Within 24 hours after the procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Columbia University Medical Center — New York
Identifiers
NCT: NCT06954792 · AAAV0931