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

NCT03831087 | Completed

• 1 other identifier: 20171002-1653
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

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.

  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

Study Arms (2)

TAVR-CMR

OTHER

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

TAVR-CT

OTHER

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

Interventions

TAVR-CMR DIAGNOSTIC_TEST

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

TAVR-CMR

TAVR-CT DIAGNOSTIC_TEST

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

TAVR-CT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Johannes Kepler University of Linz: collaborator
• Klinikum Wels-Grieskirchen: collaborator

Study Sites (1)

University Clinic of Internal Medicine III

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (3)

• Lechner I, Oberhollenzer F, Tiller C, Holzknecht M, Kaser A, Binder RK, Gollmann-Tepekoylu C, Klug G, Mayr A, Bauer A, Metzler B, Reindl M, Reinstadler SJ. Age and sex-related outcomes in cardiovascular magnetic resonance versus computed tomography-guided transcatheter aortic valve replacement: a secondary analysis of a randomized clinical trial. J Cardiovasc Magn Reson. 2025 Summer;27(1):101882. doi: 10.1016/j.jocmr.2025.101882. Epub 2025 Mar 13.

  PMID: 40089160 DERIVED

• Reindl M, Lechner I, Holzknecht M, Tiller C, Fink P, Oberhollenzer F, von der Emde S, Pamminger M, Troger F, Kremser C, Lassnig E, Danninger K, Binder RK, Ulmer H, Brenner C, Klug G, Bauer A, Metzler B, Mayr A, Reinstadler SJ. Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial. Circulation. 2023 Oct 17;148(16):1220-1230. doi: 10.1161/CIRCULATIONAHA.123.066498. Epub 2023 Aug 27.

  PMID: 37634187 DERIVED

• Klug G, Reinstadler S, Troger F, Holzknecht M, Reindl M, Tiller C, Lechner I, Fink P, Pamminger M, Kremser C, Ulmer H, Bauer A, Metzler B, Mayr A. Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR). Trials. 2022 Sep 2;23(1):726. doi: 10.1186/s13063-022-06638-6.

  PMID: 36056444 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Bernhard Metzler, Prof.

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: October 30, 2017
• Primary Completion: August 5, 2023
• Study Completion: August 5, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)