Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
NCT02979587 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
Conditions Studied
Interventions
- DEVICE Harmony TPV System
Study Locations (12)
California
- Ronald Regan UCLA Medical Center — Los Angeles
- Stanford University Medical Center — Palo Alto
Ontario
- The Hospital for Sick Children (SickKids) — Toronto
- Toronto General Hospital — Toronto
Connecticut
- Yale University — New Haven
Minnesota
- Mayo Clinic — Rochester
Ohio
- Nationwide Children's Hospital — Columbus
Pennsylvania
- The Children's Hospital of Philadelphia — Philadelphia
Texas
- Texas Children's Hospital — Houston
Utah
- Primary Children's Hospital — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-01 |
| Est. Completion | 2031-02 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02979587
The ClinicalTrials.gov registry entry for NCT02979587 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 Medtronic Heart Valves, which has 1 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: NCT02979587 reports 12 study locations spanning 10 distinct geographic areas — top geographies include California, Ontario, Connecticut. 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 NCT02979587 about?
NCT02979587 is a clinical study titled "The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study". The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
What is the current status of trial NCT02979587?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 86 participants. The study started on 2017-01. Estimated completion is 2031-02.
What conditions does trial NCT02979587 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 NCT02979587?
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 NCT02979587?
This trial is sponsored by Medtronic Heart Valves, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02979587 being conducted?
This trial has 12 study locations across California, Connecticut, Minnesota, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.