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

Medical University Innsbruck267 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

267

Conditions

Aortic Stenosis

Interventions

TAVR-CMRDIAGNOSTIC_TEST

CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

TAVR-CTDIAGNOSTIC_TEST

CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University Clinic of Internal Medicine III

Innsbruck, Tyrol, Austria

Outcomes

Primary Outcomes

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.

The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient \< 20mmHg and no valve regurgitation \> mild)

Time frame: 6 months

Data from ClinicalTrials.gov

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