DF4 Connector System Post-Approval Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/22/2019 |
| Start Date: | January 2012 |
| End Date: | March 2019 |
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.
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.
Inclusion Criteria:
- Subject or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
- Subject is intended to be implanted or is within 30 days post-implant of a DF4
Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or
defibrillation application
Exclusion Criteria:
- Subject who is, or will be inaccessible for follow-up at a study site
- Subject with exclusion criteria required by local law (Europe, Central Asia [ECA]
only)
- Implant and follow-up data, including any adverse device effects and system
modifications at implant through the time of enrollment are unavailable
We found this trial at
73
sites
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