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NCT02347189 · ClinicalTrials.gov registry record · NA
Melody PB1016 Surveillance Study
A NA study, sponsored by Medtronic Heart Valves.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT02347189: Completed NA study, sponsored by Medtronic Heart Valves.
NCT02347189 is a NA study that has completed, run by Medtronic Heart Valves. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347189, a NA study, has completed, sponsored by Medtronic Heart Valves.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
Primary Outcome
Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implanta
Interventions
- DEVICE Melody Transcatheter Pulmonary Valve PB1016
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-11 |
| Est. Completion | 2018-08-10 |
| Phase | NA |
What the finished NCT02347189 record still lists
NCT02347189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Melody Transcatheter Pulmonary Valve PB1016 is the first listed.
NCT02347189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02347189 about?
NCT02347189 is a clinical study titled "Melody PB1016 Surveillance Study". Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
What is the current status of trial NCT02347189?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2014-11. Estimated completion is 2018-08-10.
What interventions are being tested in trial NCT02347189?
The interventions under investigation include: Melody Transcatheter Pulmonary Valve PB1016 (DEVICE).
Who is sponsoring clinical trial NCT02347189?
This trial is sponsored by Medtronic Heart Valves, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02347189's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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