Clinical trialNCT03130777Active, not recruitingInterventional

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

SponsorEdwards LifesciencesEnrollment86Congenital Heart DiseasePulmonary DiseasePulmonary RegurgitationTetralogy of FallotTranscatheter Pulmonary Valve Replacement (TPVR)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Evan Zahn, MD, FACC, FSCAI
Cedars-Sinai Heart Institute
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Emory University/ Children'S Healthcare of Atlanta (choa)
Atlanta, Georgia, United States
St. Louis Children'S Hospital
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Cincinnati Children'S Hospital
Cincinnati, Ohio, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
Children'S Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Health Dallas
Dallas, Texas, United States
Texas Children'S Hospital
Houston, Texas, United States
University of Virgina
Charlottesville, Virginia, United States
Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Aug 2017
Primary completion: 14 Jul 2022
Completion: 30 Jun 2032
Last update posted: 20 Oct 2026
Registered enrollment: 86
Registry id: NCT03130777

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.