Alterra Prestent + SAPIEN 3 Valve for Heart Disease

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byEvan Zahn, MD, FACC, FSCAI

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

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.

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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.

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Treatment Details

Interventions

Edwards Alterra Adaptive Prestent (Prestent)
Edwards SAPIEN 3 THV (Transcatheter Heart Valve)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: TPVR - PDS RegistryExperimental Treatment1 Intervention

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

Group II: TPVR - Main CohortExperimental Treatment1 Intervention

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