Supra-Annular vs. Annular ValvEs for Small Annuli (SAVE)

Marvin Eng

Status: Invitation-only

Conditions: Aortic Valve Stenosis; Implantation, Heart Valve Prosthesis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04372381

STUDY00000164

Details and patient eligibility

About

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Full 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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Supra-Annular transcatheter heart valve

Active Comparator group

Description:

Medtronic Evolut Pro Valve implantation

Treatment:

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

Annular transcatheter heart valve

Active Comparator group

Description:

Edwards Sapien 3 Ultra implantation

Treatment:

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