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NCT05077774 · ClinicalTrials.gov registry record · NA
Harmony TPV Post-Approval Study
A NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT05077774 is a NA study of Congenital Heart Disease and Pulmonary Regurgitation that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 150 participants, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT05077774, a NA study of Congenital Heart Disease and Pulmonary Regurgitation, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Conditions Studied
Interventions
- DEVICE Harmony TPV System
Study Locations (20)
New York
- The Mount Sinai Hospital - New York
- Children's Hospital New York - Presbyterian - New York
North Carolina
- Atrium Health Levine Children's Hospital - Charlotte
- Duke University Medical Center - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Cleveland Clinic - Cleveland
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
California
- Cedars Sinai Medical Center - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Florida
- St. Joseph Children's Hospital - Tampa
Illinois
- Advocate Christ Medical Center - Oak Lawn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-10-25 |
| Est. Completion | 2035-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077774
The ClinicalTrials.gov registry entry for NCT05077774 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 472-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (68% lower). The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Harmony TPV System is the first listed.
NCT05077774 reports 20 study locations spanning 17 distinct geographic areas - top geographies include New York, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05077774 about?
NCT05077774 is a clinical study titled "Harmony TPV Post-Approval Study". The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
What is the current status of trial NCT05077774?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-10-25. Estimated completion is 2035-03.
What conditions does trial NCT05077774 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Pulmonary Regurgitation, Tetrology of Fallot, RVOT Anomaly.
What interventions are being tested in trial NCT05077774?
The interventions under investigation include: Harmony TPV System (DEVICE).
Who is sponsoring clinical trial NCT05077774?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077774 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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