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Enrolling by Invitation

NCT Number: NCT06954792

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

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).

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Interventional Cardiology Structural Heart Disease Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mortality Rate

    Time frame: 1 Year

    The prognosis of AHI after TTVR will be measured as the rate of all cause mortality in comparison to the control group.

Secondary outcomes

  1. Number of Participants with Coronary Artery Disease (CAD)

    Time frame: Baseline (Day 0)

    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.

  2. Number of Participants with Right Ventricular (RV) Dysfunction

    Time frame: Baseline (Day 0)

    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.

  3. Number of Participants with Pulmonary Hypertension

    Time frame: Baseline (Day 0)

    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.

  4. Number of Participants with Primary Left Ventricular Cardiomyopathy

    Time frame: Baseline (Day 0)

    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.

  5. Number of Participants with Post-Procedural Fever

    Time frame: Within 48 hours after the procedure

    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.

  6. Number of Participants with Post-procedural Inflammatory Response

    Time frame: Within 48 hours after the procedure

    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.

  7. Number of Participants with AHI

    Time frame: Within 24 hours after the procedure

    Number of Participants with AHI among all the population screened

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement

Acronym: TTVR-AHI

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
May 2, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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