Supra-Annular vs. Annular ValvEs for Small Annuli
- Conditions
- Aortic Valve StenosisImplantation, Heart Valve Prosthesis
- Interventions
- Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
- Registration Number
- NCT04372381
- Lead Sponsor
- Marvin Eng
- 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-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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supra-Annular transcatheter heart valve Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro Medtronic Evolut Pro Valve implantation Annular transcatheter heart valve Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro Edwards Sapien 3 Ultra implantation
- Primary Outcome Measures
Name Time Method Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation 1 month
- Secondary Outcome Measures
Name Time Method VARC-2 30-day early safety and efficacy 30 days 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
Pacemaker implantation 30 days Clinical indication for permanent pacemaker insertion
Prosthetic Valve Dysfunction 30 days and 1 year Mean aortic valve gradient \>= 20 mmHg
\>= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis
Trial Locations
- Locations (3)
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
Banner - University Medical Center, Phoenix campus
🇺🇸Phoenix, Arizona, United States