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| Name | Class |
|---|---|
| Johannes Kepler University of Linz | OTHER |
| Klinikum Wels-Grieskirchen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR-CMR | Diagnostic Test | CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard Metzler, Prof. | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Internal Medicine III | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40089160 | Derived | 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. | |
| 37634187 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| TAVR-CT | Diagnostic Test | CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route. |
|
| 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. |
| 36056444 | 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. |
| D014694 |
| Ventricular Outflow Obstruction |