SAPIEN 3 Valve for Pulmonary Valve Dysfunction

Recruiting at 20 trial locations

Overseen By Edwards THV Clinical Affairs

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must not be taking: Antibiotics, Antiplatelets

Disqualifiers: Infection, Endocarditis, Blood disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-5 days

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a heart valve treatment called the SAPIEN 3 for individuals with issues in the pulmonary valve area of the heart. It focuses on those needing repair for a faulty connection or valve on the heart's right side. Participants should have a history of pulmonary valve issues and significant heart-related symptoms. The trial aims to determine if this treatment is safe and effective for addressing these specific heart problems. As an unphased trial, it offers patients a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity to aspirin or heparin and cannot be treated with other similar medications, you may not be eligible to participate.

What prior data suggests that the SAPIEN 3/SAPIEN 3 Ultra RESILIA THV is safe for pulmonary valve dysfunction?

Research has shown that the SAPIEN 3 and SAPIEN 3 Ultra RESILIA heart valves are safe for individuals with certain heart valve problems. Studies have found that these valves performed well and remained safe for up to a year in patients with dysfunctional right ventricular outflow tract (RVOT) conduits or those with previously misplaced valves.

The SAPIEN 3 valve consists of durable materials, such as cobalt-chromium, and includes components made from specially treated cow tissue. This design enhances the valve's longevity and reduces complications. Reports from previous patients indicated that the valve was well-tolerated, with no major safety concerns.

Overall, the evidence supports the safety of these heart valves for individuals with specific heart issues, making them a promising treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAPIEN 3 and SAPIEN 3 Ultra RESILIA transcatheter heart valves (THV) because they bring a new level of innovation to treating pulmonary valve dysfunction. Unlike traditional surgical valve replacements, which require open-heart surgery, these devices offer a minimally invasive approach through transcatheter pulmonary valve replacement (TPVR). This means less recovery time and reduced risks associated with major surgery. Additionally, the SAPIEN 3 Ultra RESILIA valve features advanced tissue technology designed to increase durability and resistance to calcification, potentially extending the lifespan of the valve and improving patient outcomes. These advancements could significantly enhance the quality of life for patients with dysfunctional right ventricular outflow tract (RVOT) conduits or previously implanted valves.

What evidence suggests that the SAPIEN 3 Valve is effective for pulmonary valve dysfunction?

Research has shown that the SAPIEN 3 and SAPIEN 3 Ultra RESILIA heart valves, studied in this trial, effectively address problems in the pulmonary valve area. Participants will undergo transcatheter pulmonary valve replacement (TPVR) using these valves. Studies have found these valves safe and effective for treating issues with the right side of the heart's outflow tract or previously implanted valves. One study reported low rates of complications, such as the need for additional procedures, and improved blood flow. Another study confirmed these results, showing low death rates and excellent ongoing outcomes for patients. These findings suggest that these heart valves are a reliable choice for those needing valve replacement in the pulmonary position. ^{1 2 3 5 6}

Who Is on the Research Team?

Scott Lim, MD

Principal Investigator

University of Virginia Medical Center

Vasilis Babaliaros, MD

Principal Investigator

Emory University Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals weighing at least 44 lbs with a dysfunctional heart valve or conduit in the pulmonic position, requiring intervention and having specific measurements. Participants must not have active infections, blood disorders, recent procedures, or severe non-cardiac diseases affecting life expectancy. Pregnant women and those with certain allergies are excluded.

Inclusion Criteria

I weigh at least 44 pounds.

I need a procedure for my heart valve and the area where it will be placed fits the required size.

The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

You have low white blood cell, red blood cell, or platelet counts, or a known blood clotting disorder.

I am not currently on antibiotics for an infection, or it has been 2 weeks since I finished them.

I have a planned surgery or heart procedure within 30 days after the TPVI procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcatheter pulmonary valve replacement (TPVR) using the SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems

1-5 days

In-hospital stay for procedure and recovery

Follow-up

Participants are monitored for safety and effectiveness, including assessment of THV dysfunction and device success

1 year

Regular follow-up visits, including TTE assessments

What Are the Treatments Tested in This Trial?

Interventions

• SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

Trial Overview The study tests the safety and effectiveness of Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems in patients needing pulmonary valve replacement due to dysfunction. It aims to improve heart function by replacing the faulty valve without open-heart surgery.

How Is the Trial Designed?

Group I: TPVR- S3UR Registry Experimental Treatment 2 Interventions

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Group II: TPVR - THV Registry Experimental Treatment 2 Interventions

Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.

Group III: TPVR - Main Cohort Experimental Treatment 1 Intervention

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

SAPIEN 3/SAPIEN 3 Ultra RESILIA THV is already approved in United States, European Union for the following indications:

Approved in United States as Edwards SAPIEN 3 for:

• Severe aortic stenosis
• Failing mitral valve previously repaired with a prosthetic ring
• Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position

Approved in European Union as Edwards SAPIEN 3 for:

• Severe aortic stenosis
• Failing mitral valve previously repaired with a prosthetic ring
• Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position

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

In a study involving 774 patients across 23 centers, transcatheter pulmonary valve replacement (TPVR) using Sapien XT or S3 valves showed a high technical success rate of 97.4%, indicating that this procedure is generally safe and effective for various right ventricular outflow tract anatomies.

While most patients had excellent valve function post-implantation, 10% experienced serious adverse events, including tricuspid valve complications in 3% of patients, highlighting the need for careful monitoring and longer follow-up to assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. Shahanavaz, S., Zahn, EM., Levi, DS., et al.[2021]

In a study involving 50 patients with congenital heart disease and dysfunctional right ventricular outflow tracts, the use of the Edwards Sapien S3 valve for percutaneous transcatheter pulmonary valve replacement (TPVR) was technically successful with no cases of valve embolization or significant obstruction during short-term follow-up.

While the procedure showed excellent short-term valve function and safety, there were some major complications, including tricuspid valve injuries, highlighting the need for careful procedural techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial results from the off-label use of the SAPIEN S3 valve for percutaneous transcatheter pulmonary valve replacement: A multi-institutional experience. Sinha, S., Aboulhosn, J., Asnes, J., et al.[2020]

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 Ultra (S3-Ultra) system significantly reduced the incidence of ≥mild paravalvular leakage (PVL) compared to the SAPIEN 3 (S3) system, with rates of 7.2% versus 22.3%, indicating improved efficacy in valve performance.

Patients receiving the S3-Ultra also experienced a lower incidence of major vascular complications (4.5% vs. 11.4%), suggesting that the S3-Ultra may offer comparable safety benefits alongside its improved hemodynamic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry. Moriyama, N., Lehtola, H., Miyashita, H., et al.[2021]

In a study involving 58 patients with dysfunctional right ventricular outflow tract conduits or pulmonic valves, the SAPIEN 3 transcatheter heart valve (THV) demonstrated a high device success rate of 98.1% at discharge, indicating its efficacy in treating significant pulmonary regurgitation and stenosis.

At the 1-year follow-up, the primary endpoint of THV dysfunction was only 4.3%, with no major adverse events reported, highlighting the safety of the SAPIEN 3 valve in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). Lim, DS., Kim, D., Aboulhosn, J., et al.[2023]

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]

The Sapien 3 Ultra (S3U) transcatheter heart valve was successfully implanted in 30 patients with high-grade aortic stenosis, showing excellent performance and no procedural complications, even in cases of significant aortic valve calcification.

Post-procedure assessments indicated that paravalvular leakage was minimal, with only 2 patients experiencing mild aortic insufficiency, and a high 30-day survival rate of 96.7%, demonstrating the valve's efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Edwards Sapien 3 Ultra Transcatheter Aortic Valve System in Patients With Aortic Stenosis and Annulus Diameter in Proximity to Valve Size. Ong, P., Hill, S., Baumbach, H., et al.[2021]

The SAPIEN 3 Ultra transcatheter heart valve features a 40% taller external skirt compared to the previous SAPIEN 3 valve, which may enhance its performance and stability during implantation.

The delivery system for the SAPIEN 3 Ultra remains the same as the S3, ensuring proven deliverability and maintaining low rates of vascular complications, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation balloon-expandable transcatheter heart valve: the SAPIEN 3 Ultra valve. Chatfield, A., Sathananthan, J., Wood, DA., et al.[2022]

Transcatheter pulmonary valve replacement (TPVR) using the Sapien S3 valve has been made easier with a new delivery technique, which is important for patients with significant pulmonary valve diseases.

This novel technique may lower the risk of injury to the tricuspid valve during the procedure, addressing a common complication associated with using stiffer delivery systems in the right ventricular outflow tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified delivery of SAPIEN 3 valve in the pulmonary position: Evolution of technique or dire need? Shahanavaz, S., Rockefeller, T., Nicolas, R., et al.[2020]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S162C.pdf

Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN ... The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet RESILIA bovine ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20565300

Evaluation of the SAPIEN 3 Transcatheter Heart Valve in ... The SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the pulmonic position to 1 year.

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT02744677

Evaluation of the SAPIEN 3 Transcatheter Heart Valve in ... This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36608435/

Congenital Pulmonic Valve Dysfunction Treated With ... In conclusion, the SAPIEN 3 THV was safe and effective in patients with dysfunctional RVOT conduits or previously implanted valves in the ...

5. ir.edwards.com ir.edwards.com/news/news-details/2024/Edwards-SAPIEN-3-Ultra-RESILIA-Valve-Demonstrates-Continued-Excellent-Outcomes-for-Patients-in-Real-World-Data/default.aspx

Edwards' SAPIEN 3 Ultra RESILIA Valve Demonstrates ... Patients receiving the SAPIEN 3 Ultra RESILIA valve experienced extremely low mortality, low rates of reintervention, larger effective orifice ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S182D.pdf

Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN ... The Edwards SAPIEN 3 Ultra RESILIA transcatheter heart valve is comprised of a balloon-expandable, radiopaque, cobalt- chromium frame, trileaflet RESILIA bovine ...