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NCT03130777 · ClinicalTrials.gov registry record · NA

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

A NA study of Congenital Heart Disease and Pulmonary Disease, sponsored by Edwards Lifesciences.

Active
Registry status
NA
Development phase
86
Enrollment target
14
Study locations

NCT03130777: Active NA study of Congenital Heart Disease and Pulmonary Disease, sponsored by Edwards Lifesciences.

NCT03130777 is a NA study of Congenital Heart Disease and Pulmonary Disease that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 86 participants, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (82% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03130777, a NA study of Congenital Heart Disease and Pulmonary Disease, is active but no longer recruiting, sponsored by Edwards Lifesciences.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
86 participants
Enrollment target
14
Study locations

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.

Primary Outcome

Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE

Conditions Studied

Congenital Heart Disease Pulmonary Disease Tetralogy of Fallot Pulmonary Regurgitation Transcatheter Pulmonary Valve Replacement (TPVR)

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
Edwards Lifesciences

57 total trials

What the registry record for NCT03130777 still lists

NCT03130777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (82% lower).

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.

NCT03130777 lists 14 locations in 10 states (California, Ohio, Texas).

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).

What interventions are being tested in trial NCT03130777?

The interventions under investigation include: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV (DEVICE).

Who is sponsoring clinical trial NCT03130777?

This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Congenital Heart Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03130777's enrollment target sits among peer trials

86 33rd of 63 higher than 30 of 63 other Congenital Heart Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03130777, the US trial registry maintained by the National Library of Medicine. NCT03130777 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.