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

NCT04522154 | Completed

• 1 other identifier: HDZ-KA_017_MG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (7)

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

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

  3 month

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

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

  3 Month

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

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

  3 Month

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

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

  3 Month

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

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

  3 Month

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

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

  3 Month

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

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

  3 Month

Secondary Outcomes (5)

• Exercise Testing with 6 min walking test

  3 month

• rehospitalization rate

  3 month

• Stroke

  3 month

• Death due to cardiovascular complication

  3 month

• Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity

  3 month

Study Arms (1)

MR-TTE

OTHER

Patient receiving cardiac magnet resonance imaging and echocardiography

Diagnostic Test: Magnet resonance imaging

Interventions

Magnet resonance imaging DIAGNOSTIC_TEST

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

MR-TTE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Muhammed Gercek, Dr. med.

  Assistant physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: August 1, 2020
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)