RECRUITINGINTERVENTIONAL
MRI in Transcatheter Aortic Valve Replacement Patients
Comparison of Hemodynamic Performance of Transcatheter Aortic Valve Replacement With Supra-Annular Self-Expanding Versus Balloon-Expandable Valves Assessed by Exercise Cardiovascular Magnetic Resonance
About This Trial
The hypothesis is that SEV result in superior valvular hemodynamics (more pronounced during exercise) and exercise capacity relative to BEV. Furthermore, the hypothesis is that stress CMR will be able to demonstrate differences in these hemodynamic parameters. CMR will also provide refined assessment of paravalvular leak and its impact on ventricular function and on clinical outcomes.
Who May Be Eligible (Plain English)
Who May Qualify:
- Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
- Planned transfemoral TAVR; 18 years of age or older;
- Able to give willing to sign a consent form.
Who Should NOT Join This Trial:
- Patients with permanent pacemakers or implantable defibrillators;
- Patients with non-MRI safe implants;
- Severe claustrophobia;
- Inability or contraindication to perform exercise bike stress test;
- Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
- Reduced left ventricular systolic function (\<40%);
- History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
- Significant non-treated coronary artery disease.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Aortic valve stenosis with clinical indication for valve replacement decided by a dedicated heart team;
* Planned transfemoral TAVR; 18 years of age or older;
* Able to give informed consent.
Exclusion Criteria:
* Patients with permanent pacemakers or implantable defibrillators;
* Patients with non-MRI safe implants;
* Severe claustrophobia;
* Inability or contraindication to perform exercise bike stress test;
* Arrhythmia which would prevent adequate cardiac gating, including atrial fibrillation;
* Reduced left ventricular systolic function (\<40%);
* History of surgical aortic valve replacement or patients who undergo a valve-in-valve TAVR procedures;
* Significant non-treated coronary artery disease.
Treatments Being Tested
DEVICE
Self-expanding valve (Medtronic Evolut FX)
Bioprothesis Medtronic Evolut FX supra-annular self-expanding valve
DEVICE
Balloon-expanding valve (Edwards Sapien 3 Ultra RESILIA)
Bioprosthesis Edwards Sapien 3 Ultra valve
Locations (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States