Heart Failure Clinical Trial
— 4968Official title:
Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study
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.
Status | Completed |
Enrollment | 370 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Alaska Heart Institute | Anchorage | Alaska |
Lead Sponsor | Collaborator |
---|---|
Medtronic |
United States, Australia, Austria, Belgium, Canada, Denmark, Former Serbia and Montenegro, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival Probability of the Model 4968 Lead Based on Lead-related Complications | The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability. | The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety. | No |
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