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Completed

NCT Number: NCT03831087

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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic of Internal Medicine III

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1)
  • Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope
  • Patient is evaluated for TAVR

Exclusion criteria

  • Contraindications to perform CMR
  • Contraindications to perform CT
  • Contraindications for TAVR or reduced life expectancy < 1 year.
  • Known hypersensitivity to CMR or CT contrast agents
  • Childbearing potential or inability to exclude pregnancy
  • Inability to understand and follow study-related instructions
  • Severe renal insufficiency requiring renal replacement therapy
  • Severe hepatic insufficiency (Child-Pugh class B or C)
  • Post organ transplantation
  • Participation in another clinical study

Treatment and study plan

TAVR-CMR

Diagnostic Test

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

TAVR-CT

Diagnostic Test

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

Primary outcomes

  1. 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.

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • Johannes Kepler University of Linz
  • Klinikum Wels-Grieskirchen

Registry information

Official study title

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

Acronym: TAVR-CMR

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2019
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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