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

H

Heart and Diabetes Center North-Rhine Westfalia

Status

Completed

Conditions

Tricuspid Valve Insufficiency

Treatments

Diagnostic Test: Magnet resonance imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT04522154
HDZ-KA_017_MG

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

MR-TTE
Other group
Description:
Patient receiving cardiac magnet resonance imaging and echocardiography
Treatment:
Diagnostic Test: Magnet resonance imaging

Trial contacts and locations

1

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Central trial contact

Muhammed Gercek, Dr. med

Data sourced from clinicaltrials.gov

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