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NCT02979587 · ClinicalTrials.gov registry record · NA
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
A NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Heart Valves.
- Active
- Registry status
- NA
- Development phase
- 86
- Enrollment target
- 12
- Study locations
NCT02979587: Active NA study of Congenital Heart Disease and Pulmonary Regurgitation, sponsored by Medtronic Heart Valves.
NCT02979587 is a NA study of Congenital Heart Disease and Pulmonary Regurgitation that is active but no longer recruiting, run by Medtronic Heart Valves. 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 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02979587, a NA study of Congenital Heart Disease and Pulmonary Regurgitation, is active but no longer recruiting, sponsored by Medtronic Heart Valves.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 86 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
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 |
What the registry record for NCT02979587 still lists
NCT02979587 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 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.
NCT02979587 lists 12 locations in 10 states (California, Ontario, Connecticut).
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.
What interventions are being tested in trial NCT02979587?
The interventions under investigation include: Harmony TPV System (DEVICE).
Who is sponsoring clinical trial NCT02979587?
This trial is sponsored by Medtronic Heart Valves, which has 3 total clinical trials registered on ClinicalTrials.gov.
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
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 NCT02979587'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.
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