Model 4965 Post-Approval Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:3/1/2019
Start Date:September 1996
End Date:April 2011

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

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

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.

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)
We found this trial at
85
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