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Completed

NCT Number: NCT04522154

Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging

There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.

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Key information

Conditions

Tricuspid Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.

Exclusion criteria

  • Patient with Incompatibility with magnetic resonance imaging or echocardiography
  • Another valve disorder that requires treatment
  • Severe precapillary pulmonary hypertension
  • Unstable angina or percutaneous coronary intervention within the last 30 days
  • Previous pacemaker/defibrillator implantation with intracardiac leads
  • Patients with cardiac cachexia or a life expectancy less then 12 months
  • Allergies to the material used.

Treatment and study plan

Magnet resonance imaging

Diagnostic Test

Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure

Primary outcomes

  1. Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography

    Time frame: 3 month

    Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention

  2. Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention

  3. Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention

  4. Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention

  5. Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention

  6. Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention

  7. Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography

    Time frame: 3 Month

    Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention

Secondary outcomes

  1. Exercise Testing with 6 min walking test

    Time frame: 3 month

    Changes on walked distance after transcatheter tricuspid intervention

  2. rehospitalization rate

    Time frame: 3 month

    Detection of rehospitalization rate after transcatheter tricuspid intervention

  3. Stroke

    Time frame: 3 month

    Detection of stroke rate after transcatheter tricuspid intervention

  4. Death due to cardiovascular complication

    Time frame: 3 month

    Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention

  5. Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity

    Time frame: 3 month

    Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram)

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2020
Registry last updated
Mar 12, 2025

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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