Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)
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-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Treatment of aortic valve stenosis using transcatheter aortic valve replacement
Banner - University Medical Center, Phoenix campus
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Delray Medical Center
Delray Beach, Florida, United States
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Time frame: 1 month
VARC-2 30-day early safety and efficacy
All cause mortality stroke life-threatening bleeding acute kidney injury-stage 2 or 3 coronary artery obstruction major vascular complication valve-related dysfunction requiring repeat procedure NYHA class III or IV Requiring hospitalization for valve-related symptoms or worsening congestive heart failure
Time frame: 30 days
Pacemaker implantation
Clinical indication for permanent pacemaker insertion
Time frame: 30 days
Prosthetic Valve Dysfunction
Mean aortic valve gradient \>= 20 mmHg \>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis
Time frame: 30 days and 1 year
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