NCT01076361

Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 370 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

Detailed description

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Conditions

• Arrhythmia
• Heart Failure

Timeline

• Start date: 1999-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-02-26
• Last updated: 2014-10-27
• Results posted: 2014-10-27

Locations

106 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Serbia and Montenegro, Spain, Sweden, Switzerland