Status:
COMPLETED
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement
Lead Sponsor:
Medical University Innsbruck
Collaborating Sponsors:
Johannes Kepler University of Linz
Klinikum Wels-Grieskirchen
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18-99 years
Phase:
NA
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.
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, Uni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2023
Estimated Enrollment :
267 Patients enrolled
Trial Details
Trial ID
NCT03831087
Start Date
October 30 2017
End Date
August 5 2023
Last Update
August 9 2023
Active Locations (1)
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1
University Clinic of Internal Medicine III
Innsbruck, Tyrol, Austria, 6020