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Trial record 1 of 1 for:    NCT03831087
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Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR)

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ClinicalTrials.gov Identifier: NCT03831087
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : August 9, 2023
Sponsor:
Collaborators:
Johannes Kepler University of Linz
Klinikum Wels-Grieskirchen
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Diagnostic Test: TAVR-CMR Diagnostic Test: TAVR-CT Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : August 5, 2023
Actual Study Completion Date : August 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
TAVR-CMR
All MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D "whole-heart" coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA.
 Diagnostic Test: TAVR-CMR
CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
TAVR-CT
All CT examinations will be performed on a 128-slice dual-source CT and high-pitch factor. Prospective electrocardiographic synchronization will be applied, triggered into the diastolic phase for the heart. An injected bolus of 70 to 110 mL of nonionic iodine contrast agent will be applied with 370 mg/mL iodine concentration, using an automatic injector at a flow rate of 5 mL/s, followed by 40 mL saline solution. Contrast agent volume for each patient will be calculated by scan time and body weight. Patients will be placed supine with arms overhead. The scan length range from supraaortic branches to the groins.
 Diagnostic Test: TAVR-CT
CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.


Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831087


Locations
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Austria
University Clinic of Internal Medicine III
Innsbruck, Tirol, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Johannes Kepler University of Linz
Klinikum Wels-Grieskirchen
Investigators
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Principal Investigator: Bernhard Metzler, Prof. Medical University Innsbruck
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03831087    
Other Study ID Numbers: 20171002-1653
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction