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NCT01638897 · ClinicalTrials.gov registry record
DF4 Connector System Post-Approval Study
A clinical trial, sponsored by Medtronic.
- Completed
- Registry status
- 1,778
- Enrollment target
NCT01638897: Completed study, sponsored by Medtronic.
NCT01638897 is a clinical trial that has completed, run by Medtronic. The registered enrollment target is 1,778 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01638897 has completed, sponsored by Medtronic.
- COMPLETED
- Registry status
- 1,778 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
Primary Outcome
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,778 participants |
| Start Date | 2012-01 |
| Est. Completion | 2019-03 |
What the finished NCT01638897 record still lists
NCT01638897 is an observational study that tracks outcomes without assigning an intervention. Its 1,778 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01638897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01638897 about?
NCT01638897 is a clinical study titled "DF4 Connector System Post-Approval Study". The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after im...
What is the current status of trial NCT01638897?
This trial is currently completed. The enrollment target is 1,778 participants. The study started on 2012-01. Estimated completion is 2019-03.
Who is sponsoring clinical trial NCT01638897?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
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