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NCT00676689 · ClinicalTrials.gov registry record · NA
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
NCT00676689 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 81 participants.
The verdict
NCT00676689, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
Study Summary
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.
Interventions
- DEVICE SAPIEN Transcatheter Valve Implantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2008-04-08 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00676689
The ClinicalTrials.gov registry entry for NCT00676689 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SAPIEN Transcatheter Valve Implantation is the first listed.
NCT00676689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00676689 about?
NCT00676689 is a clinical study titled "COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV". To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of \>=35mmHg) by TTE.
What is the current status of trial NCT00676689?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2008-04-08. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT00676689?
The interventions under investigation include: SAPIEN Transcatheter Valve Implantation (DEVICE).
Who is sponsoring clinical trial NCT00676689?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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