TAVR Valves for Aortic Valve Stenosis

(SAVE Trial)

Recruiting at 3 trial locations

Overseen By Kacorri, Ardit, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Marvin Eng

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Marvin Eng, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for individuals with severe aortic valve stenosis and an aortic valve annulus mean diameter of 23 mm or less. They must be symptomatic, meet the criteria for transcatheter aortic valve replacement (TAVR), and have suitable anatomy. Excluded are those who can't consent, are pregnant or planning pregnancy, at risk of coronary obstruction, have certain types of low-flow heart conditions, need other heart procedures, or have poor kidney function not managed by dialysis.

Inclusion Criteria

My heart team has approved me for a valve replacement without open surgery.

I have severe narrowing of my heart's aortic valve causing symptoms.

The width of your aortic valve is less than 23 millimeters.

Exclusion Criteria

I have a specific heart valve condition with reduced blood flow.

Pregnancy or intent on becoming pregnant prior to completion of all protocol follow-up procedures

Subject unable or unwilling to provide informed consent

Treatment Details

Interventions

• Edwards Sapien Ultra (Transcatheter Aortic Valve Replacement)
• Medtronic Evolut Pro (Transcatheter Aortic Valve Replacement)

Trial Overview The study compares two types of heart valves in patients with small annuli: Supra-annular valves (Medtronic Evolut Pro) versus annular valves (Edwards Sapien Ultra). It's an open-label trial where participants will know which treatment they receive and will be randomly assigned to one of the two options.

Participant Groups

Group I: Supra-Annular transcatheter heart valve Active Control 1 Intervention

Medtronic Evolut Pro Valve implantation

Group II: Annular transcatheter heart valve Active Control 1 Intervention

Edwards Sapien 3 Ultra implantation

Who Is Running the Clinical Trial?

Marvin Eng

Lead Sponsor

Trials

1

Recruited

150+

William Beaumont Hospitals

Collaborator

Trials

153

Recruited

113,000+