Supra-Annular vs. Annular ValvEs for Small Annuli

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2025-06-30

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)

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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.

Conditions

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Aortic Valve Stenosis Implantation, Heart Valve Prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-Label, Prospective randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supra-Annular transcatheter heart valve

Medtronic Evolut Pro Valve implantation

Group Type ACTIVE_COMPARATOR

Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Intervention Type DEVICE

Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Annular transcatheter heart valve

Edwards Sapien 3 Ultra implantation

Group Type ACTIVE_COMPARATOR

Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Intervention Type DEVICE

Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Interventions

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Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro

Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Intervention Type DEVICE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No