Brief Title
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
Official Title
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial
Brief 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: 2017-2020. 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.
Study Type
Interventional
Primary Outcome
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.
Condition
Aortic Stenosis
Intervention
TAVR-CMR
Study Arms / Comparison Groups
TAVR-CMR
Description: All MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D "whole-heart" coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
250
Start Date
October 30, 2017
Completion Date
June 1, 2022
Primary Completion Date
June 1, 2021
Eligibility Criteria
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. Killip class ≥ 3 6. Childbearing potential or inability to exclude pregnancy 7. Inability to understand and follow study-related instructions 8. Severe renal insufficiency requiring renal replacement therapy 9. Severe hepatic insufficiency (Child-Pugh class B or C) 10. Post organ transplantation 11. Participation in another clinical study
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Bernhard Metzler, Prof., 00435125040, [email protected]
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03831087
Organization ID
20171002-1653
Responsible Party
Sponsor
Study Sponsor
Medical University Innsbruck
Collaborators
Johannes Kepler University of Linz
Study Sponsor
Bernhard Metzler, Prof., Principal Investigator, Medical University Innsbruck
Verification Date
February 2020