N/A
Completed N=370
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
Source: ClinicalTrials.gov NCT01076361 ↗Enrolled (actual)
370
Serious AEs
8.6%
Results posted
Oct 2014
Primary outcomePrimary: Survival Probability of the Model 4968 Lead Based on Lead-related Complications — 92.3 percentage of Model 4968 Leads
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Probability of the Model 4968 Lead Based on Lead-related Complications |
92.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01076361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.