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NCT01660035 · ClinicalTrials.gov registry record
The Product Surveillance Registry REVERSE Post Approval Study
A clinical trial, sponsored by Medtronic.
- Completed
- Registry status
- 155
- Enrollment target
NCT01660035: Completed study, sponsored by Medtronic.
NCT01660035 is a clinical trial that has completed, run by Medtronic. The registered enrollment target is 155 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01660035 has completed, sponsored by Medtronic.
- COMPLETED
- Registry status
- 155 participants
- Enrollment target
Study Summary
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
Primary Outcome
To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2012-04 |
| Est. Completion | 2022-04 |
What the finished NCT01660035 record still lists
NCT01660035 is an observational study that tracks outcomes without assigning an intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01660035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01660035 about?
NCT01660035 is a clinical study titled "The Product Surveillance Registry REVERSE Post Approval Study". The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
What is the current status of trial NCT01660035?
This trial is currently completed. The enrollment target is 155 participants. The study started on 2012-04. Estimated completion is 2022-04.
Who is sponsoring clinical trial NCT01660035?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
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