Status:
UNKNOWN
Supra-Annular vs. Annular ValvEs for Small Annuli
Lead Sponsor:
Marvin Eng
Collaborating Sponsors:
Corewell Health East
Conditions:
Aortic Valve Stenosis
Implantation, Heart Valve Prosthesis
Eligibility:
All Genders
Phase:
NA
Brief Summary
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Detailed Description
Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expandi...
Eligibility Criteria
Inclusion
- Symptomatic subjects with severe native aortic valve stenosis
- aortic valve annulus mean diameter ≤23 mm
- Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
- Institutional heart team determines that TAVR is appropriate
- Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra
Exclusion
- Subject unable or unwilling to provide informed consent
- Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
- Renal function precluding the administration of iodinated contrast (eGFR \< 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
- Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
- Patients at high risk for coronary obstruction
- Patients with low-flow low gradient aortic valve stenosis
- patients at high risk for annular rupture with implantation of a balloon expandable valve
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04372381
Start Date
May 12 2020
End Date
June 1 2025
Last Update
January 27 2023
Active Locations (3)
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1
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, United States, 85006
2
Tucson Medical Center
Tucson, Arizona, United States, 85712
3
Delray Medical Center
Delray Beach, Florida, United States, 33484