Brief Title
Supra-Annular vs. Annular ValvEs for Small Annuli
Official Title
Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)
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 Type
Interventional
Primary Outcome
Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation
Secondary Outcome
VARC-2 30-day early safety and efficacy
Condition
Aortic Valve Stenosis
Intervention
Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Study Arms / Comparison Groups
Supra-Annular transcatheter heart valve
Description: Medtronic Evolut Pro Valve implantation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
150
Start Date
May 4, 2020
Completion Date
May 4, 2023
Primary Completion Date
May 4, 2021
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Marvin Eng, 3139167452, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04372381
Organization ID
55
Responsible Party
Sponsor-Investigator
Study Sponsor
Marvin Eng
Collaborators
William Beaumont Hospitals
Study Sponsor
Marvin Eng, Principal Investigator, Henry Ford Hospital
Verification Date
April 2020