SAPIEN 3 Valve for Pulmonary Valve Dysfunction

Recruiting at19 trial locations

Overseen by Vasilis Babaliaros, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Edwards Lifesciences

Must not be taking: Antibiotics, Antiplatelets

Disqualifiers: Infection, Endocarditis, Blood disorders, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests a special heart valve that can be inserted without open-heart surgery. It targets patients with faulty heart valves in the pulmonic position. The new valve is delivered through a tube and helps the heart pump blood properly. The Direct Flow Medical valve has been developed with several important revisions to improve the efficacy and safety of the procedure.

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 data supports the effectiveness of the SAPIEN 3 Valve for Pulmonary Valve Dysfunction treatment?

The SAPIEN 3 and SAPIEN 3 Ultra valves have shown good outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis, with improvements in valve performance and low rates of complications. These results suggest that the SAPIEN 3 technology may also be effective for pulmonary valve dysfunction. ^{1 2 3 4 5}

What makes the SAPIEN 3 Valve treatment unique for pulmonary valve dysfunction?

The SAPIEN 3 Valve treatment is unique because it offers a transcatheter approach to replace the pulmonary valve, which is less invasive than traditional surgery. It features a novel delivery technique that simplifies placement in the right ventricular outflow tract and reduces the risk of injury to nearby heart structures. ^{2 6 7 8 9}

Research Team

Scott Lim, MD

Principal Investigator

University of Virginia Medical Center

Vasilis Babaliaros, MD

Principal Investigator

Emory University Hospitals

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• SAPIEN 3/SAPIEN 3 Ultra RESILIA THV (Transcatheter Heart Valve)

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.

Participant Groups

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).

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

Findings from Research

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 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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves: Comparison of SAPIEN 3 Ultra Versus SAPIEN 3. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Next-generation balloon-expandable transcatheter heart valve: the SAPIEN 3 Ultra valve. [2022]

3. United States 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial). [2023]

7. United States 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Modified delivery of SAPIEN 3 valve in the pulmonary position: Evolution of technique or dire need? [2020]