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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-08-22 |
| Est. Completion | 2032-06 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (82% lower). The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 10 distinct geographic areas - top geographies include 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.
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