Alterra Prestent + SAPIEN 3 Valve for Heart Disease

Not currently recruiting at 14 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, Antithrombotics

Disqualifiers: Infection, Endocarditis, Drug use, 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 for individuals with heart issues involving the pulmonary valve, specifically those with pulmonary regurgitation (a condition where the heart's valve doesn't close tightly, causing blood to leak back into the heart). The study evaluates the safety and effectiveness of using two devices together: the Edwards Alterra Adaptive Prestent (a supportive device for heart valves) and the Edwards SAPIEN 3 valve (a transcatheter heart valve). Participants will receive one of two different methods of device delivery. Ideal candidates for this trial have been diagnosed with moderate or severe pulmonary regurgitation and meet specific size requirements for their heart's anatomy. As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an active infection requiring antibiotics, you must wait two weeks after stopping them to be eligible.

What prior data suggests that the Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV are safe for treating pulmonary regurgitation?

Research has shown that the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) system, used with the Alterra Adaptive Prestent, has been tested for safety and effectiveness. An early study found that this combination is safe and effective for patients with certain heart valve problems.

Like any medical procedure, some risks are involved. Possible risks for this valve system include serious issues like heart stoppage or other heart-related problems. However, these risks are generally rare and depend on individual health factors.

The FDA has already approved the Edwards SAPIEN 3 valve for other uses, indicating a known safety record. This suggests that doctors understand how it functions in the body.

Overall, past patients have generally tolerated the treatment well, but discussing potential risks with a healthcare professional is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Alterra Prestent combined with the SAPIEN 3 Valve because it introduces a novel approach to treating heart disease. Unlike traditional treatments that may involve open-heart surgery, this duo is delivered using minimally invasive systems—the Commander Delivery System and the Pulmonic Delivery System (PDS). These delivery methods aim to simplify the implantation process, potentially reducing recovery times and risks associated with more invasive procedures. Additionally, the adaptive design of the Alterra Prestent provides a customized fit, which could enhance the effectiveness and durability of the valve replacement. This innovative approach promises to improve patient outcomes and broaden treatment options for those with specific heart conditions.

What evidence suggests that the Edwards Alterra Adaptive Prestent and SAPIEN 3 THV could be effective for pulmonary regurgitation?

Research has shown that the Edwards Alterra Adaptive Prestent combined with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) system effectively treats pulmonary regurgitation (PR). This trial will evaluate this combination in two treatment arms: one using the Commander Delivery System and the other using the Pulmonic Delivery System (PDS). Studies have found that this combination can improve heart function by reducing the backward flow of blood on the heart's right side. Known for providing excellent results, this treatment may delay the need for additional procedures. Patients may also experience a better quality of life due to more efficient heart function. The SAPIEN 3 valve, already used for other heart issues, has a strong record of safety and effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Evan Zahn, MD, FACC, FSCAI

Principal Investigator

Cedars-Sinai Heart Institute

Are You a Good Fit for This Trial?

This trial is for individuals weighing at least 44 lbs with certain heart conditions like Tetralogy of Fallot, who have moderate or severe pulmonary regurgitation. They must have specific measurements in their heart's outflow tract and agree to the study terms. People can't join if they've had recent medical procedures, drug abuse history, are pregnant, have serious non-cardiac diseases, infections requiring antibiotics, blood disorders or known allergies to specific metals and medications.

Inclusion Criteria

The size of the landing zone in the heart's pulmonary valve area is between 27mm and 38mm, and the distance from the heart's contracting tissue to the lowest pulmonary artery takeoff is at least 35mm.

I weigh at least 44 pounds.

You have moderate or severe pulmonary regurgitation as seen in a heart ultrasound.

Exclusion Criteria

I haven't had any surgery or interventional procedures in the last 30 days.

I have a surgery or heart-related procedure planned within 30 days after my valve implant.

Your body doesn't have the right shape for the Alterra Adaptive Prestent or the SAPIEN 3 THV to be put in.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using either Commander or Pulmonic Delivery System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

Continued Access

Subjects are eligible for enrollment in the continued access phase of the trial

What Are the Treatments Tested in This Trial?

Interventions

• Edwards Alterra Adaptive Prestent
• Edwards SAPIEN 3 THV

Trial Overview The ALTERRA trial tests the safety and effectiveness of combining two devices: the Edwards Alterra Adaptive Prestent and SAPIEN 3 THV System. This combo aims to treat patients with dysfunctional right ventricular outflow tracts/pulmonary valves due to congenital heart defects.

How Is the Trial Designed?

Group I: TPVR - PDS Registry Experimental Treatment 1 Intervention

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).

Group II: TPVR - Main Cohort Experimental Treatment 1 Intervention

Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.

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 Sapien 3 transcatheter heart valve (S3 THV) was successfully implanted in 54 high-risk patients with aortic stenosis, showing excellent clinical outcomes with 97.8% of patients experiencing no or mild aortic regurgitation at 30 days post-procedure.

The study reported a low incidence of complications, with only 3.7% of patients experiencing stroke or all-cause mortality, and all patients improved to New York Heart Association Functional Class I or II, indicating significant functional improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve. Wendt, D., Al-Rashid, F., Kahlert, P., et al.[2022]

In a study of 11 Thai patients with pulmonary arterial hypertension (PAH) associated with congenital heart disease, bosentan treatment for 6 months significantly improved the 6-minute walk test (6MWT) distances and oxygen saturation levels, particularly in patients with Eisenmenger physiology.

The treatment was found to be safe, with no significant increase in liver enzymes, indicating that bosentan can be a beneficial option for managing severe PAH in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of bosentan in pulmonary arterial hypertension associated with congenital heart disease. Durongpisitkul, K., Jakrapanichakul, D., Sompradikul, S.[2018]

In a study of 30 stable pulmonary arterial hypertension (PAH) patients transitioning from sitaxsentan to either ambrisentan or bosentan, no significant changes in hemodynamic parameters or functional class were observed over 4 months, indicating safety in switching therapies.

While most patients remained stable, a small number experienced increased cardiac filling pressures and mild side effects, such as fluid retention and elevated liver enzymes, suggesting careful monitoring is still necessary during transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic stability after transitioning between endothelin receptor antagonists in patients with pulmonary arterial hypertension. Fox, B., Langleben, D., Hirsch, AM., et al.[2018]

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]

Citations

1. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-heart/transcatheter-sapien-3-valve-pulmonic

Transcatheter pulmonary valve replacement Deliver excellent outcomes, potentially delay reintervention, and improve quality of life for more of your patients. · References · Important Safety Information ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03130777

SAPIEN 3 THV With the Alterra Adaptive Prestent To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200015S011D.pdf

Edwards SAPIEN 3 Transcatheter Pulmonary Valve ... The Edwards SAPIEN 3 transcatheter pulmonary valve system with Alterra adaptive prestent consists of the. Edwards 29-mm SAPIEN 3 transcatheter heart valve (THV) ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33069657/

Alterra Adaptive Prestent and SAPIEN 3 THV for ... Objectives: The aim of this study was to demonstrate the safety and functionality of the Alterra Adaptive Prestent and SAPIEN 3 transcatheter ...

5. heartvalves.com heartvalves.com/pulmonic

Pulmonic | HeartValves Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with the Alterra Adaptive Prestent. A library of resources to help you support your pulmonic patients. As ...

6. heartvalves.com heartvalves.com/isi-alterra

Important Safety Information - Alterra - HeartValves Contraindications: The Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent is contraindicated in patients who cannot tolerate ...