NCT03831087

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.

Detailed 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. Planned Study Period: 2017-2023. 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): 270 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TAVR-CMR	CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
DIAGNOSTIC_TEST	TAVR-CT	CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

Timeline

• Start date: 2017-10-30
• Primary completion: 2023-08-05
• Completion: 2023-08-05
• First posted: 2019-02-05
• Last updated: 2023-08-09

Locations

1 site across 1 country: Austria