NCT01638897

DF4 Connector System Post-Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,778 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Tachycardia
• Ventricular Fibrillation
• Sudden Cardiac Death
• Heart Failure

Timeline

• Start date: 2012-01-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2012-07-12
• Last updated: 2019-03-20

Locations

78 sites across 3 countries: United States, Canada, France