Supra-Annular vs. Annular ValvEs for Small Annuli

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supra-Annular vs. Annular ValvEs for Small Annuli (<= 23mm)

Conditions
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Aortic Valve Stenosis, Implantation, Heart Valve Prosthesis

Intervention / Treatment
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* Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-Label, Prospective randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supra-Annular transcatheter heart valve<br>Medtronic Evolut Pro Valve implantation | Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro<br>* Treatment of aortic valve stenosis using transcatheter aortic valve replacement<br>|
| Active Comparator: Annular transcatheter heart valve<br>Edwards Sapien 3 Ultra implantation | Device: Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro<br>* Treatment of aortic valve stenosis using transcatheter aortic valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 
| Pacemaker implantation | Clinical indication for permanent pacemaker insertion | 30 days | 
| Prosthetic Valve Dysfunction | Mean aortic valve gradient >= 20 mmHg >= Moderate transvalvular aortic regurgitation Abnormal leaflet thickening Decreased leaflet mobility Leaflet thrombosis | 30 days and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implantation, Heart Valve Prosthesis, aortic valve stenosis, transcatheter aortic valve replacement