Alterra Prestent + SAPIEN 3 Valve for Heart Disease

Recruiting at 13 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

86 Participants Needed

Trial Summary

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.

Is the Alterra Prestent + SAPIEN 3 Valve generally safe for humans?

The Alterra Prestent and SAPIEN 3 Valve have been studied for safety in patients with heart valve issues, showing promising results. The SAPIEN 3 Valve has been used in high-risk patients and was found to be as safe as traditional surgery, with improvements to reduce risks like vascular injury and leakage. ^{1 2 3 4 5}

How is the Alterra Prestent + SAPIEN 3 Valve treatment unique for heart disease?

The Alterra Prestent + SAPIEN 3 Valve treatment is unique because it combines a specialized prestent with a transcatheter heart valve, offering a minimally invasive option for heart valve replacement, which can be particularly beneficial for patients who are not candidates for traditional open-heart surgery. ^{6 7 8 9 10}

What is the purpose of this trial?

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Research Team

Evan Zahn, MD, FACC, FSCAI

Principal Investigator

Cedars-Sinai Heart Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

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

Alterra Adaptive Prestent and SAPIEN 3 THV for Congenital Pulmonic Valve Dysfunction: An Early Feasibility Study. [2021]

2. France pubmed.ncbi.nlm.nih.gov

Edwards SAPIEN 3 valve. [2012]

3. United States 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. [2013]

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

First human implant of the Alterra Adaptive PrestentTM : A new self-expanding device designed to remodel the right ventricular outflow tract. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve. [2022]

6. Thailand pubmed.ncbi.nlm.nih.gov

A retrospective study of bosentan in pulmonary arterial hypertension associated with congenital heart disease. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Sitaxsentan, a selective endothelin-A receptor antagonist for the treatment of pulmonary arterial hypertension. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

A review of sitaxsentan sodium in patients with pulmonary arterial hypertension. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Hemodynamic stability after transitioning between endothelin receptor antagonists in patients with pulmonary arterial hypertension. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Successful switch to sitaxsentan in a patient with HIV-related pulmonary arterial hypertension and late intolerance to nonselective endothelin receptor blockade. [2016]