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Prestent

Alterra Prestent + SAPIEN 3 Valve for Heart Disease

N/A
Waitlist Available
Led By Evan Zahn, MD, FACC, FSCAI
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight is ≥ 20 kg (44 lbs).
Must not have
Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart valve to see if it is safe and effective in people with a dysfunctional right ventricular outflow tract/pulmonary valve. If the trial is successful, subjects will be eligible for enrollment in the continued access phase.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications related to device placement such as bleeding or infection at the insertion site, allergic reactions to materials in the devices or contrast media used during implantation, irregular heartbeat patterns (arrhythmias), valve leakage or migration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh at least 44 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a surgery or heart-related procedure planned within 30 days after my valve implant.
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My non-heart related illness may shorten my life to under a year.
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I am allergic to aspirin or heparin and cannot take similar medications.
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My kidney function is low or I am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Main Cohort: THV Dysfunction
PDS Registry: Acute PDS Success
Secondary study objectives
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,022 Total Patients Enrolled
1 Trials studying Tetralogy of Fallot
150 Patients Enrolled for Tetralogy of Fallot
Evan Zahn, MD, FACC, FSCAIPrincipal InvestigatorCedars-Sinai Heart Institute

Media Library

Edwards Alterra Adaptive Prestent (Prestent) Clinical Trial Eligibility Overview. Trial Name: NCT03130777 — N/A
Tetralogy of Fallot Research Study Groups: TPVR - Main Cohort, TPVR - PDS Registry
Tetralogy of Fallot Clinical Trial 2023: Edwards Alterra Adaptive Prestent Highlights & Side Effects. Trial Name: NCT03130777 — N/A
Edwards Alterra Adaptive Prestent (Prestent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03130777 — N/A
~11 spots leftby Nov 2025
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