An observational study in Tricuspid Regurgitation, Heart Failure and Structural Heart Disease, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Columbia University · Observational
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).
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's planned enrollment of 140 is below the median of 200 across 96 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients undergoing TTVR without presenting any AHI post-procedurally
Patients undergoing TTVR and presenting AHI within 24h after the procedure
Mortality Rate
The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.
Time frame: 1 Year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 48 hours after the procedure
Number of Participants with AHI
Number of Participants with AHI among all the population screened
Time frame: Within 24 hours after the procedure
Plan to share: Undecided
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