TAVR for Aortic Stenosis

(PII S3i Trial)

Recruiting at 50 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Inoperability, Complex coronary disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

1074 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, and severe aortic stenosis, and those with intermediate risk.

Research Team

Martin B Leon, MD

Principal Investigator

Columbia University

Craig Smith, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for patients with severe, symptomatic aortic stenosis who are at intermediate risk. They must have heart valve issues confirmed by specific tests and be able to follow up for five years post-procedure. It's not suitable for those deemed inoperable, unstable, needing emergency surgery, or with complex coronary artery disease.

Inclusion Criteria

I agree to follow all the study's required check-ups, including phone calls, for 5 years.

My heart valve is severely narrowed, confirmed by an echo test within the last 60 days.

I have symptoms from a heart valve problem and it affects my daily activities.

Exclusion Criteria

A team of heart specialists has determined I cannot have heart surgery.

I haven't needed heart or lung support machines in the last 30 days.

I require emergency surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Edwards SAPIEN 3 transcatheter heart valve via transfemoral, transapical, or transaortic delivery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• Edwards SAPIEN 3

Trial Overview The PARTNER II Trial is testing the Edwards SAPIEN 3 transcatheter heart valve in patients with calcific aortic stenosis. The goal is to assess its safety and effectiveness compared to standard treatments in individuals at intermediate surgical risk.

Participant Groups

Group I: PIIS3i - SAPIEN 3 Experimental Treatment 1 Intervention

PIIS3i - SAPIEN 3 is Operable Group

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