Clinical trial NCT03831087: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Johannes Kepler University of Linz
name: Klinikum Wels-Grieskirchen
First posted: 2019-02-05
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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: 2017-2023.

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.

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. 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Clinic of Internal Medicine III
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Bernhard Metzler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klug G, Reinstadler S, Troger F, Holzknecht M, Reindl M, Tiller C, Lechner I, Fink P, Pamminger M, Kremser C, Ulmer H, Bauer A, Metzler B, Mayr A. Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR). Trials. 2022 Sep 2;23(1):726. doi: 10.1186/s13063-022-06638-6.