Supra-Annular vs. Annular ValvEs for Small Annuli

Aortic Valve Stenosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04372381
• Other study ID #: STUDY00000164
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: June 2025

Study information

• Verified date: January 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Implantation, Heart Valve Prosthesis

Intervention

Device:
• Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro
Treatment of aortic valve stenosis using transcatheter aortic valve replacement

Locations

Country	Name	City	State
United States	Delray Medical Center	Delray Beach	Florida
United States	Banner - University Medical Center, Phoenix campus	Phoenix	Arizona
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Marvin Eng	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of patient prosthesis mismatch and >= moderate paravalvular regurgitation		1 month
Secondary	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
Secondary	Pacemaker implantation	Clinical indication for permanent pacemaker insertion	30 days
Secondary	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