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

Completed

• Conditions: Arrhythmia; Heart Failure

• Registration Number: NCT01076361
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2013-06-28
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-24
• Last Update Submitted: 2014-10-24
• Results First Posted: 2014-10-27
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
• Availability of implant, follow-up, and product-related event data
• Implanted with a Model 4968 Capsure Epi Lead

Exclusion Criteria

• Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
• Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
• Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
• Subjects with exclusion criteria required by local law

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival Probability of the Model 4968 Lead Based on Lead-related Complications	The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety.	The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.

Trial Locations

Locations (1)

Alaska Heart Institute; 🇺🇸 Anchorage, Alaska, United States