NCT01076348

Model 4965 Post-Approval Study

Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).

Detailed description

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Conditions

• Heart Failure
• Pacing
• Bradycardia
• Arrhythmia

Timeline

• Start date: 1996-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-02-26
• Last updated: 2019-02-27
• Results posted: 2012-08-23

Locations

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