Model 4965 Post-Approval Study

Completed

• Conditions: Arrhythmia; Heart Failure; Pacing; Bradycardia

• Registration Number: NCT01076348
• Lead Sponsor: Medtronic

Brief 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.

Study Timeline

• Study Start: 1996-09
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-05-16
• Results First Submitted QC: 2012-07-09
• Results First Posted: 2012-08-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB

AND one of the following (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

• product is market-released
• complete implant and follow-up data, including product-related adverse events, are available
• subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

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 SLS 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 (EMEA only)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Model 4965 Complication Free Rate	1 year	A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.