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

Medtronic

Status: Completed

Conditions: Arrhythmia; Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT01076361

4968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 patients

Sex: All

Volunteers: No Healthy Volunteers

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