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

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.

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.

Inclusion Criteria:

1. Signed informed consent
2. Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1)
3. Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope
4. Patient is evaluated for TAVR

Exclusion Criteria:

1. Contraindications to perform CMR
2. Contraindications to perform CT
3. Contraindications for TAVR or reduced life expectancy < 1 year.
4. Known hypersensitivity to CMR or CT contrast agents
5. Childbearing potential or inability to exclude pregnancy
6. Inability to understand and follow study-related instructions
7. Severe renal insufficiency requiring renal replacement therapy
8. Severe hepatic insufficiency (Child-Pugh class B or C)
9. Post organ transplantation
10. Participation in another clinical study