SAPIEN 3 THV for Aortic Stenosis

(P3 Trial)

Not currently recruiting at 78 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must not be taking: Antithrombotics, Anticoagulants

Disqualifiers: Coronary artery disease, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Expected average of 7 days for hospitalization

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) for individuals with severe aortic stenosis, a condition where the heart’s aortic valve narrows. Participants will either receive the new valve through a minimally invasive procedure or undergo traditional surgical valve replacement. Suitable candidates for this trial include those with severe aortic stenosis who experience symptoms such as reduced exercise ability or other heart-related issues. As an unphased trial, this study provides patients the opportunity to contribute to important research that could enhance treatment options for severe aortic stenosis.

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 THV is safe for aortic stenosis?

Research has shown that the SAPIEN 3 Transcatheter Heart Valve (THV) is generally well-tolerated by patients. One study found that only 0.8% of patients died from any cause within 30 days of the procedure, indicating that serious complications are rare shortly after the procedure. Another analysis found that the 5-year rates of death and disabling stroke were similar between those who received the SAPIEN 3 THV and those who underwent traditional surgical valve replacement. This finding suggests that the long-term safety of the SAPIEN 3 THV is comparable to standard surgery. Additionally, reports indicate very low rates of serious side effects, meaning most people did not experience severe issues soon after receiving the valve. Overall, these findings suggest the SAPIEN 3 THV is a safe option for treating severe aortic stenosis, which is the narrowing of the heart's aortic valve. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the SAPIEN 3 Transcatheter Heart Valve (THV) for aortic stenosis because it offers a less invasive alternative to traditional surgical aortic valve replacement (SAVR). Unlike SAVR, which requires open-heart surgery, the SAPIEN 3 THV is delivered via a catheter, making it a transcatheter aortic valve replacement (TAVR) option. This approach can reduce recovery time and is often suitable for patients who are considered high-risk for conventional surgery. Additionally, the advanced design of the SAPIEN 3 THV aims to improve the fit and function of the valve, potentially enhancing patient outcomes and durability compared to earlier transcatheter valves.

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

This trial will compare two treatment options for severe aortic stenosis: Transcatheter Aortic Valve Replacement (TAVR) using the SAPIEN 3 Transcatheter Heart Valve (THV) and Surgical Aortic Valve Replacement (SAVR). Research has shown that the SAPIEN 3 THV effectively treats severe aortic stenosis, a condition where the heart valve narrows. After five years, patients who received the SAPIEN 3 valve experienced similar outcomes to those who underwent traditional open-heart surgery for valve replacement, with no major differences in the main outcomes. The SAPIEN 3 valve also maintained excellent performance over the long term, with results comparable to surgery even after seven years. Early reports indicate very low rates of complications just 30 days after the procedure. Overall, evidence supports the SAPIEN 3 THV as an effective option for managing aortic stenosis, offering a less invasive alternative with results comparable to traditional surgery. ^{1 4 5 6 7}

Who Is on the Research Team?

Michael J Mack, MD, FACC

Principal Investigator

The Heart Hospital Baylor Plano, TX

Martin B Leon, MD, FACC

Principal Investigator

Columbia University Medical Center/ New York Presbyterian Hospital, NY

Are You a Good Fit for This Trial?

The PARTNER 3 Trial is for patients with severe, calcified aortic stenosis who are at low risk for standard valve replacement surgery. Participants must have symptoms or test results showing heart function issues and agree to the study's terms. Those with recent strokes, extreme obesity, short life expectancy, refusal of blood products, certain infections or diseases, unsuitable heart valve sizes or conditions that prevent safe procedure completion cannot join.

Inclusion Criteria

A group of heart doctors decides that the patient has a high risk of dying from surgery and has a Society of Thoracic Surgeons (STS) score of less than 4.

I have heart issues affecting my daily activities or exercise ability.

I have severe narrowing of my heart's aortic valve with calcium buildup.

Exclusion Criteria

I have a history of cirrhosis or currently have liver disease.

I have a blood disorder affecting my white cells, red cells, or platelets.

I have not had active bacterial endocarditis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or surgical aortic valve replacement (SAVR)

Expected average of 7 days for hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at discharge, 30 days, 6 months, and annually through 10 years

10 years

What Are the Treatments Tested in This Trial?

Interventions

• SAPIEN 3 THV

Trial Overview This trial tests the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve (THV) compared to standard surgical aortic valve replacement (SAVR). It targets patients with severe aortic stenosis but considered low-risk for traditional surgery. The goal is to see if THV can be an alternative treatment option.

How Is the Trial Designed?

Group I: Transcatheter aortic valve replacement (TAVR) Experimental Treatment 1 Intervention

Group II: Surgical aortic valve replacement (SAVR) Active Control 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

Published Research Related to This Trial

The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.

Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. Barbash, IM., Dvir, D., Waksman, R.[2013]

In a study of 85 patients undergoing TAVR with the SAPIEN 3 valve, nonagenarians (aged 90 and above) experienced similar early mortality rates compared to younger patients, indicating that TAVR is a viable option for elderly patients with severe aortic stenosis.

However, nonagenarians had a higher incidence of life-threatening bleeding and major vascular complications (11.8% vs. 1.5% in younger patients), suggesting that while TAVR is safe, older patients may face greater procedural risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early mortality and safety after transcatheter aortic valve replacement using the SAPIEN 3 in nonagenarians. Ichimoto, E., Arnofsky, A., Wilderman, M., et al.[2022]

In a study of 1077 intermediate-risk patients undergoing TAVR with the SAPIEN 3 valve, the 1-year all-cause mortality rate was low at 7.4%, with only 2% experiencing disabling strokes, indicating the procedure's safety and efficacy.

When compared to surgical aortic valve replacement, TAVR demonstrated both non-inferior and superior outcomes for the composite endpoint of mortality, strokes, and moderate or severe aortic regurgitation, suggesting it may be the preferred treatment for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Thourani, VH., Kodali, S., Makkar, RR., et al.[2022]

The Sapien 3 transcatheter heart valve (S3-THV) significantly reduced the incidence of at least mild aortic regurgitation (15.9% vs. 46.2%) compared to the previous Sapien XT valve (SXT-THV), indicating improved valve performance.

The S3-THV also showed enhanced safety with no major bleeding or vascular complications reported, while maintaining similar rates of pacemaker implantation and 30-day mortality compared to the SXT-THV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve implantation with the new balloon-expandable Sapien 3 versus Sapien XT valve system: a propensity score-matched single-center comparison. Nijhoff, F., Abawi, M., Agostoni, P., et al.[2016]

The SAPIEN XT transcatheter heart valve system is associated with significantly fewer overall and major vascular complications compared to the original SAPIEN system, making it a safer option for patients with severe aortic stenosis who cannot undergo surgery.

Both SAPIEN and SAPIEN XT systems showed similar effectiveness in reducing all-cause mortality, major stroke, and rehospitalization rates at one year, indicating that the newer SAPIEN XT system maintains therapeutic efficacy while improving safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. Webb, JG., Doshi, D., Mack, MJ., et al.[2022]

The SAPIEN XT transcatheter heart valve demonstrated a primary composite safety rate of 12.1% at 30 days in a study of 199 Australian patients with severe aortic stenosis, indicating it is a safe option for those at intermediate surgical risk.

The procedure significantly improved heart function, with 90.9% of patients achieving New York Heart Association class I/II status by 30 days and a reduction in mean aortic gradient from 50.0 mmHg at baseline to 10.3 mmHg at 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance and Safety of Transfemoral TAVI With SAPIEN XT in Australian Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: SOLACE-AU Trial. Yong, G., Walton, T., Ng, M., et al.[2021]

In a study of 310 patients undergoing transcatheter aortic valve replacement (TAVR) with either the SAPIEN 3 Ultra or SAPIEN 3 valves, both devices showed high rates of device success and low adverse event rates within 30 days post-procedure.

The SAPIEN 3 Ultra valve demonstrated improved annular sealing properties, resulting in significantly lower rates of mild paravalvular leakage compared to the SAPIEN 3, despite requiring less pre-dilatation during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves: Comparison of SAPIEN 3 Ultra Versus SAPIEN 3. Rheude, T., Pellegrini, C., Lutz, J., et al.[2021]

Transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 valve is a safe and effective alternative to traditional surgical aortic valve replacement (SAVR) for patients with severe aortic stenosis, showing lower rates of complications.

Recent trials have demonstrated that the SAPIEN 3 valve significantly reduces vascular complications and paravalvular leakage, with lower stroke and mortality rates than expected in high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Edwards SAPIEN 3 Transcatheter Valve For Aortic Stenosis. Htun, NM., Webb, JG.[2016]

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. 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 ... SAPIEN 3, which showed superiority at 1 year, also demonstrates compelling outcomes equivalent to surgery at seven years.

4. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2023/07/05/15/14/outcomes-of-sapien-3

SAPIEN 3 TAVR vs. SAVR in Intermediate-Risk Patients In a propensity-matched analysis of intermediate-risk patients, 5-year rates of death or disabling stroke were similar between S3 TAVR and SAVR.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02675114

Study Details | NCT02675114 | PARTNER 3 Trial: Safety ... A prospective, randomized, controlled, multi-center study to establish the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve in low risk ...

6. jacc.org jacc.org/doi/10.1016/j.jacc.2025.09.1348

TCT-1135 Safety and efficacy of Transcatheter aortic valve ... Prosthetic valves smaller than 26 mm were implanted in nearly half of the patients (50%). The 30-day all-cause mortality rate was 0.8%, with no ...

7. 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 ...