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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03831087
Other study ID # 20171002-1653
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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