SAPIEN 3 Ultra System for Aortic Stenosis

No longer recruiting at 6 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the SAPIEN 3 Ultra System for individuals with severe aortic stenosis, a condition where the heart valve narrows, hindering blood flow. The goal is to evaluate the safety and effectiveness of this system for those at some risk with traditional heart surgery. The trial involves Transcatheter Aortic Valve Replacement (TAVR), a less invasive procedure than open-heart surgery. Suitable candidates have severe aortic stenosis and are considered at intermediate risk for surgery. As an unphased trial, this study provides patients with access to innovative treatment options that could enhance their quality of life.

Do I need to stop my current medications for the trial?

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

What prior data suggests that the SAPIEN 3 Ultra System is safe for aortic stenosis?

Research shows that the SAPIEN 3 Ultra System is generally well-tolerated by patients. One study found good results with this system after one year, including a reduction in issues like paravalvular leaks, which are unwanted leaks around the valve. Another study compared the SAPIEN 3 with standard surgery and found similar rates of death and serious strokes over five years for patients at intermediate risk. While the long-term durability of the valve remains uncertain, current data suggests it performs well in the short term. Regular medical check-ups are recommended to monitor the valve's function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SAPIEN 3 Ultra System is unique because it offers a less invasive option for treating aortic stenosis compared to traditional surgical aortic valve replacement. This system uses a transcatheter aortic valve replacement (TAVR) approach, which means the valve is delivered to the heart through a catheter, usually inserted via a small incision in the leg. This can significantly reduce recovery time and minimize surgical risks, making it particularly beneficial for patients who are at higher risk for open-heart surgery. Researchers are excited about this treatment because it combines advanced valve technology with a patient-friendly procedure, potentially improving both outcomes and quality of life for those with aortic stenosis.

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

Research shows that the SAPIEN 3 Ultra System, which participants in this trial will receive, is a promising treatment for severe aortic stenosis, a narrowing of the heart's aortic valve. In earlier studies, this device achieved a high success rate, with 98% of procedures working well. One study found that patients who received this treatment had better outcomes after one year and required fewer repeat procedures compared to older versions. Additionally, no reports of death or stroke occurred in the hospital or within 30 days after the procedure. Overall, the SAPIEN 3 Ultra System has demonstrated better short- and medium-term results compared to traditional surgery. ^{5 6 7 8 9}

Who Is on the Research Team?

John Webb, MD

Principal Investigator

St. Paul's Hospital

Bernard Prendergast, Prof

Principal Investigator

St. Thomas Hospital

Are You a Good Fit for This Trial?

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

My heart valve is severely narrowed and has calcium deposits.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37407110/

Outcomes of SAPIEN 3 Transcatheter Aortic Valve ... There were no differences in the primary endpoint between S3 TAVR and SAVR at 5 years (40.2% vs 42.7%; HR: 0.87; 95% CI: 0.74-1.03; P = 0.10).

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824017114

1-Year Real-World Outcomes of TAVR With the Fifth ... TAVR with the S3UR is associated with superior 1-year clinical outcomes and lower gradients than its predecessors, with less PVL and low valve reintervention.

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/sapien-3-ultra-balloon-expandable-transcatheter-aortic-valve-in-hospital-and-30-day-results-from-the-multicentre-s3u-registry

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra ... The main findings are the following. 1) Device success was observed in 98% of the cases. 2) In-hospital, there were no cases of death, stroke or conversion to ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.122.062481

Economic Outcomes of Transcatheter Versus Surgical ... Between 2016 and 2017, 1000 low-risk patients with aortic stenosis were randomly assigned to TAVR with the SAPIEN 3 valve or SAVR in the PARTNER 3 trial ( ...

5. heartvalves.com heartvalves.com/therapies/tavr/outcomes

TAVR design build for differentiated outcomes - HeartValves The largest all-female analysis in symptomatic severe AS patients showed SAPIEN 3 TAVR superior to surgery at 1 year.4. In a pooled analysis of ...

6. 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 ...

7. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-heart/transcatheter-sapien-3-ultra

Transcatheter SAPIEN 3 Ultra Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical ...

8. eurointervention.pcronline.com eurointervention.pcronline.com/article/one-year-outcomes-after-transcatheter-aortic-valve-implantation-with-the-latest-generation-sapien-balloon-expandable-valve-the-s3u-registry

One-year outcomes after transcatheter aortic valve ... A study comparing 1-year outcomes of TAVI using the SAPIEN 3 Ultra vs SAPIEN 3 valves found the S3U reduced paravalvular leak rates without affecting death, ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03471065

The SAPIEN 3 Ultra System in Intermediate Risk Patients ... 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 ...