Supra-Annular vs. Annular ValvEs for Small Annuli (NCT04372381) | Clinical Trial Compass
UnknownNot Applicable
Supra-Annular vs. Annular ValvEs for Small Annuli
United States150 participantsStarted 2020-05-12
Plain-language summary
Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation