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

Aortic Stenosis Clinical Trial

— TAVR-CMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831087
• Other study ID #: 20171002-1653
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2023
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: August 5, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Diagnostic Test:
• TAVR-CMR
CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
• TAVR-CT
CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

Locations

Country	Name	City	State
Austria	University Clinic of Internal Medicine III	Innsbruck	Tirol

Sponsors (3)

Lead Sponsor	Collaborator
Medical University Innsbruck	Johannes Kepler University of Linz, Klinikum Wels-Grieskirchen

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months