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NCT00740870 · ClinicalTrials.gov registry record · NA
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
A NA study, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- NA
- Development phase
- 171
- Enrollment target
NCT00740870: Completed NA study, sponsored by Medtronic Cardiovascular.
NCT00740870 is a NA study that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 171 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00740870, a NA study, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- NA
- Development phase
- 171 participants
- Enrollment target
Study Summary
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
Primary Outcome
To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PCon
Interventions
- DEVICE Transcatheter Pulmonary Valve replacement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2007-01 |
| Est. Completion | 2020-08-21 |
| Phase | NA |
What the finished NCT00740870 record still lists
NCT00740870 is an interventional study that assigns participants to a tested intervention. The registered 171 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 (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Transcatheter Pulmonary Valve replacement is the first listed.
NCT00740870 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00740870 about?
NCT00740870 is a clinical study titled "Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort". The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, pro...
What is the current status of trial NCT00740870?
This trial is currently completed. It is a NA study. The enrollment target is 171 participants. The study started on 2007-01. Estimated completion is 2020-08-21.
What interventions are being tested in trial NCT00740870?
The interventions under investigation include: Transcatheter Pulmonary Valve replacement (DEVICE).
Who is sponsoring clinical trial NCT00740870?
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 NCT00740870's enrollment target sits among peer trials
171 612th of 2000 higher than 1,387 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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