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ACTIVE NOT RECRUITING NA

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

NCT03130777 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DEVICE Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

Study Locations (14)

California

  • Cedars-Sinai Medical Center — Los Angeles
  • University of California, Los Angeles — Los Angeles
  • University of California, San Francisco — San Francisco

Ohio

  • Cincinnati Children's Hospital — Cincinnati
  • Nationwide Children's Hospital — Columbus

Texas

  • Children's Health Dallas — Dallas
  • Texas Children's Hospital — Houston

Colorado

  • Children's Hospital Colorado — Aurora

Georgia

  • Emory University/ Children's Healthcare of Atlanta (CHOA) — Atlanta

Missouri

  • St. Louis Children's Hospital — St Louis

New York

  • Columbia University Medical Center — New York

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2017-08-22
Est. Completion 2032-06
Phase NA

Sponsor

Edwards Lifesciences

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03130777

The ClinicalTrials.gov registry entry for NCT03130777 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention — of which Edwards Alterra Adaptive Prestent with SAPIEN 3 THV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03130777 reports 14 study locations spanning 10 distinct geographic areas — top geographies include California, Ohio, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03130777 about?

NCT03130777 is a clinical study titled "ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent". 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...

What is the current status of trial NCT03130777?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2017-08-22. Estimated completion is 2032-06.

What conditions does trial NCT03130777 study?

This clinical trial studies the following conditions: Congenital Heart Disease, Pulmonary Disease, Tetralogy of Fallot, Pulmonary Regurgitation, Transcatheter Pulmonary Valve Replacement (TPVR). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03130777?

The interventions under investigation include: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03130777?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03130777 being conducted?

This trial has 14 study locations across California, Colorado, Georgia, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial