SAPIEN 3 Ultra System for Aortic Stenosis

Recruiting at 5 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Severe lung disease, Renal insufficiency, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.

Research Team

John Webb, MD

Principal Investigator

St. Paul's Hospital

Bernard Prendergast, Prof

Principal Investigator

St. Thomas Hospital

Eligibility Criteria

This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for open heart surgery. They must understand the study and consent to participate, have specific heart function classifications (NYHA class ≥ II), and meet certain echocardiogram criteria. Exclusions include complex coronary disease, intolerance to antithrombotic therapy, pregnancy in women of childbearing potential, participation in other studies, certain heart conditions like hypertrophic cardiomyopathy or valve issues, severe ventricular dysfunction or regurgitation problems.

Inclusion Criteria

The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

My heart valve is severely narrowed and has calcium deposits.

My heart team considers me at intermediate risk for open heart surgery.

Exclusion Criteria

You have a mechanical or bioprosthetic valve in your heart.

I have severe high blood pressure in the lungs.

I have kidney problems or am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TAVR) using the SAPIEN 3 Ultra System

1 day

1 visit (in-person)

Immediate Post-procedure Monitoring

Participants are monitored for procedural success and complications immediately after the procedure

1-5 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after discharge

4 weeks

Treatment Details

Interventions

• SAPIEN 3 Ultra System

Trial Overview The SAPIEN 3 Ultra System is being tested for safety and performance in replacing the aortic valve using a less invasive method than open-heart surgery. This system includes both the delivery mechanism and the actual replacement valve designed specifically for people with narrowed valves due to calcium buildup.

Participant Groups

Group I: Transcatheter Aortic Valve Replacement (TAVR) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD