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Harmony TPV Post-Approval Study
NCT05077774 · View on ClinicalTrials.gov ↗
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 |
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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. 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 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT05077774 reports 20 study locations spanning 17 distinct geographic areas — top geographies include New York, North Carolina, Ohio. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05077774?
The interventions under investigation include: Harmony TPV System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05077774?
This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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