Model 4965 Post-Approval Study

Completed

Conditions studied: Heart Failure, Pacing, Bradycardia, Arrhythmia

In brief

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

Key facts

Study ID

NCT01076348

Run by

Medtronic

People needed

73

Starts

1996-09-01

Expected to finish

2011-04-01

Last updated by the study team

2019-02-27

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Study site — Anchorage, Alaska, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Downey, California, United States
• Study site — East Palo Alto, California, United States
• Study site — Los Angeles, California, United States
• Study site — Salinas, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Clearwater, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Oak Lawn, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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