Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Arizona
- Enrollment
- 150
- Locations
- 6
- Primary Endpoint
- Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Supra-Annular transcatheter heart valve
Medtronic Evolut Pro Valve implantation
Intervention: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro (Device)
Annular transcatheter heart valve
Edwards Sapien 3 Ultra implantation
Intervention: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro (Device)
Outcomes
Primary Outcomes
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Time Frame: 1 month
Secondary Outcomes
- VARC-2 30-day early safety and efficacy(30 days)
- Pacemaker implantation(30 days)
- Prosthetic Valve Dysfunction(30 days and 1 year)
Investigators
Marvin Eng
Associate Professor, Internal Medicine
University of Arizona