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NCT01186692 · ClinicalTrials.gov registry record · NA
Melody® Transcatheter Pulmonary Valve Post-Approval Study
A NA study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 131
- Enrollment target
NCT01186692: Completed NA study, sponsored by Medtronic Cardiovascular.
NCT01186692 is a NA study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 131 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01186692, a NA study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
Primary Outcome
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic
Interventions
- DEVICE Melody® Transcatheter Pulmonary Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2010-07 |
| Est. Completion | 2017-10 |
| Phase | NA |
What the finished NCT01186692 record still lists
NCT01186692 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Melody® Transcatheter Pulmonary Valve is the first listed.
NCT01186692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01186692 about?
NCT01186692 is a clinical study titled "Melody® Transcatheter Pulmonary Valve Post-Approval Study". The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
What is the current status of trial NCT01186692?
This trial is currently completed. It is a NA study. The enrollment target is 131 participants. The study started on 2010-07. Estimated completion is 2017-10.
What interventions are being tested in trial NCT01186692?
The interventions under investigation include: Melody® Transcatheter Pulmonary Valve (DEVICE).
Who is sponsoring clinical trial NCT01186692?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01186692's enrollment target sits among peer trials
131 732nd of 2000 higher than 1,268 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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