TAVR for Aortic Stenosis

(PII S3i Trial)

No longer recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new heart valve, the Edwards SAPIEN 3, for individuals with aortic stenosis. Aortic stenosis occurs when the heart valve narrows, hindering blood flow and causing symptoms like chest pain or shortness of breath. The trial targets those with severe symptoms, where doctors believe the new valve may provide benefit. Participants should have noticeable symptoms and be willing to attend follow-up visits for up to five years. As an unphased trial, this study allows patients to contribute to important research that could enhance future treatments for aortic stenosis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Edwards SAPIEN 3 transcatheter heart valve is safe for patients with aortic stenosis?

Research has shown that the Edwards SAPIEN 3 heart valve is generally safe for people with aortic stenosis. One study found the procedure succeeded 98.2% of the time, with very few patients needing surgery afterward. Another report indicated that 30 days post-procedure, serious side effects occurred at very low rates. These findings suggest that most patients handle the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Edwards SAPIEN 3 is unique because it offers a minimally invasive alternative to traditional surgical aortic valve replacement for treating aortic stenosis. Unlike open-heart surgery, which requires a large incision and a lengthy recovery time, the SAPIEN 3 valve is delivered via a catheter, often through a small incision in the leg, making the procedure less risky and allowing for quicker recovery. Researchers are excited about the SAPIEN 3 because it can be a game-changer for patients who are considered high-risk for surgery, providing them with a safer and more efficient treatment option.

What evidence suggests that the Edwards SAPIEN 3 is effective for aortic stenosis?

Research has shown that the Edwards SAPIEN 3 valve, which participants in this trial will receive, effectively treats aortic stenosis, a condition where the heart's aortic valve narrows. One study found the procedure succeeded 98.2% of the time, indicating reliable results. Another report noted very low rates of side effects within 30 days of using the SAPIEN 3 system. Additionally, the valve has demonstrated long-lasting performance. This suggests that recipients can expect effective and durable results. ^{3 4 6 7 8}

Who Is on the Research Team?

Martin B Leon, MD

Principal Investigator

Columbia University

Craig Smith, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10293831/

The first clinical data of the SAPIEN 3 aortic valve in ... For procedural outcomes, the procedure success rate was 98.2% (Figure 1A). 5 cases were converted to surgery during the procedure. Only 1 case ...

2. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.022797

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter ... A recent report of the 30-day outcomes with the low-profile SAPIEN 3 transcatheter aortic valve replacement system demonstrated very low rates of adverse ...

3. businesswire.com businesswire.com/news/home/20251027951599/en/Edwards-SAPIEN-3-TAVR-Delivers-Proven-Long-term-Benefits-and-Valve-Performance-New-Data-Presented-at-TCT-2025

Edwards SAPIEN 3 TAVR Delivers Proven Long-term ... The data, which showed superior clinical outcomes at one year, also demonstrate excellent long-term valve performance and durability. Separately ...

4. jacc.org jacc.org/doi/10.1016/j.jcin.2024.02.015

Real-World Outcomes for the Fifth-Generation Balloon ... The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after transcatheter aortic ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2405880

Transcatheter Aortic-Valve Replacement for Asymptomatic ... Outcomes of patients with asymptomatic aortic stenosis followed up in heart valve clinics. JAMA Cardiol 2018;3:1060-1068. Go to Citation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01808287

Safety and Performance Study of the Edwards SAPIEN 3 ... The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S162B.pdf

Summary of Safety and Effectiveness Data (SSED) 1) The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter. Heart Valve system is indicated for relief of aortic stenosis in patients ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527325008344

Safety and efficacy of transcatheter aortic valve ... Largest cohort to evaluate Edwards Sapien 3 BEV in Type 0 BAV patients. •. Implantation of BEVs in patients with Type 0 BAV exhibits high safety and efficacy. •.