Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR). Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University. Plan...
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR). Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University. Planned Study Period: 2017-2020. Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points. Design: Prospective, randomized, open-label, multi-centre trial. Patients (planned): 250 patients. Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion. Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after 6 months. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 6 months, as well as a comparison of imaging procedure related variables (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus document.
Tracking Information
- NCT #
- NCT03831087
- Collaborators
- Johannes Kepler University of Linz
- Klinikum Wels-Grieskirchen
- Investigators
- Principal Investigator: Bernhard Metzler, Prof. Medical University Innsbruck