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

Completed

Conditions studied: Arrhythmia, Heart Failure

In brief

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.

Key facts

Study ID

NCT01076361

Run by

Medtronic

People needed

370

Starts

1999-09-01

Expected to finish

2010-09-01

Last updated by the study team

2014-10-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 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

Where it is running

• Study site — Gilbert, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bakersville, 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 — Indianapolis, Indiana, United States
• Alaska Heart Institute — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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