Administrative information
Title {1} | Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Trial (TAVR-CMR) |
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Trial registration {2a and 2b}. | ClinicalTrials.gov (NCT03831087) |
Protocol version {3} | 29th of July 2019. Version 4.0 |
Funding {4} | Applied. |
Author details {5a} | Klug Gert, MD1 Reinstadler Sebastian, MD, PhD1 Troger Felix, MD1,2 Holzknecht Magdalena, MD1 Reindl Martin, MD, PhD1 Tiller Christina, MD, PhD1 Lechner Ivan, MD1 Fink Priscilla, MD1 Pamminger Mathias, MD2 Kremser Christian, PhD2 Ulmer Hanno, PhD3 Bauer Axel, MD1 Metzler Bernhard, MD, MSc, FESC2 Mayr Agnes, MD2 1University Clinic of Internal Medicine III, Cardiology and Angiology, Medical University of Innsbruck, Austria 2 University Clinic of Radiology, Medical University of Innsbruck, Austria 3 Department for Medical Statistics, Informatics and Health Economy, Medical University of Innsbruck, Austria |
Name and contact information for the trial sponsor {5b} | Prof. Axel Bauer, MD Medical University of Innsbruck Anichstrasse 35 A-6020 Innsbruck Austria |
Role of sponsor {5c} | In this investigator-initiated trial the role of the sponsor is limited to ensuring the infrastructure for the trial. The principal investigator takes over the role of the sponsor regarding study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The sponsor has no authority over any of these activities. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Patient involvement
Methods
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
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Navigator-gated free breathing 3D “whole-heart” coronary MRAPlanning of the whole-heart acquisition includes the placement of a cubic field of view at the level of the bulbus aortae as identified at axial, coronal, and parasagittal localizers. The acquisition method is both cardiac triggered and respiratory gated. For an accurate respiratory gating, real-time position of the diaphragm is monitored by the use of navigator echos. A line of signal is reconstructed from each navigator echo and displayed as a trace. The boundary between the low signal intensity in the lung and the relatively high signal intensity in the liver creates an edge that can easily be detected and used as a gating signal, which accurately reflects the diaphragm position and is used to determine whether the data is accepted or rejected. The accuracy of this method allows narrow gating windows (3.5 mm) to be set for high resolution applications. Following MR parameters will be used for this “whole-heart technique”: repetition time (TR) [ms]/echo time (TE) [ms]: 356/1.57; field of view (FOV): 350 × 262 × 58 mm; matrix: 148 × 256 × 72; acquired voxel size: 1.36 × 1.36 × 0.8 mm; flip angle: 90°; and receiver bandwidth: 592 Hz/pixel.
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3D fast low-angle shot (FLASH) Gd-MRA
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Rating of aortic valve morphology (bicuspid vs tricuspid)
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Measurements of the aortic annulus at the 3 connection points (“hinge points“) of the aortic valve cusp insertion (“deepest coronary sinus points”)
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Measurements of coronary ostia heights of the left and right coronary artery (= distance from the annulus)
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Complete standardized peripheral TAVR-planning including aortic and iliac artery sizing
Criteria for discontinuing or modifying allocated interventions {11b}
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The recruitment rate of patients is not sufficient
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Serious, non-resolvable problems of quality of the collected data evolve
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Unpredictable circumstances in the particular study centers appear, which do not allow a continuation of the study
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New scientific findings during the study’s run-time do not allow a continuation of the study
Strategies to improve adherence to interventions {11c} and relevant concomitant care permitted or prohibited during the trial {11d}, adverse event reporting and harms {22}
Outcomes {12}
Primary endpoint
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Absence of procedural mortality
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Correct positioning of the prosthetic valve
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Intended performance of the prosthetic valve (mean aortic valve gradient < 20 mmHg and no valve regurgitation > mild)
Secondary endpoints
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All-cause mortality
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All strokes
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Life-threatening bleeding
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Acute kidney injury—stage 2 or 3 (including renal replacement therapy)
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Coronary artery obstruction requiring intervention
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Major vascular complications
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Valve-related dysfunction requiring repeat procedure
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All-cause mortality
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All stroke
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Hospitalization for aortic valve related symptoms or heart failure
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NYHA class III or IV
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Prosthetic valve related dysfunction (mean gradient > 20 mmHg or regurgitation > mild)
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Percentage of interpretable scans and scoring of image quality
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Percentage of patients with need for an alternative imaging method
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Duration of imaging and patient comfort
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Cumulative radiation dose during TAVR planning
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Cumulative amount of contrast agent used for TAVR planning
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Imaging related safety parameters as contrast extravasation, allergic reactions, et cetera.