Supra-Annular vs. Annular ValvEs for Small Annuli

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Marvin Eng
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Updated on 16 February 2024
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stenosis
aortic valve replacement
transcatheter aortic valve implantation
aortic stenosis

Summary

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

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.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE, Heart Valve Prosthesis Implantation
Age 100years or below
Treatment Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Clinical Study IdentifierNCT04372381
SponsorMarvin Eng
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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