Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Active, not recruiting Not applicable Interventional Results available

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

ClinicalTrials.gov ID: NCT03130777

Public ClinicalTrials.gov record NCT03130777. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 7:23 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03130777
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
86 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 22, 2017 (Actual)
Primary completion
Jul 14, 2022 (Actual)
Completion
Jun 2032 (Estimated)
Last update posted
Oct 20, 2026

2017 – 2032

United States locations

U.S. sites
14
U.S. states
10
U.S. cities
13
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California, Los Angeles Los Angeles California 90095 —
University of California, San Francisco San Francisco California 94122 —
Children's Hospital Colorado Aurora Colorado 80045 —
Emory University/ Children's Healthcare of Atlanta (CHOA) Atlanta Georgia 30322 —
St. Louis Children's Hospital St Louis Missouri 63110 —
Columbia University Medical Center New York New York 10032 —
Cincinnati Children's Hospital Cincinnati Ohio 45229 —
Nationwide Children's Hospital Columbus Ohio 43205 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Health Dallas Dallas Texas 75235 —
Texas Children's Hospital Houston Texas 77030 —
University of Virgina Charlottesville Virginia 22908 —
Seattle Children's Hospital Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03130777, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2026 · Synced Oct 27, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03130777 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →