Model 4965 Post-Approval Study
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Purpose
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
| Condition |
|---|
|
Heart Failure Pacing Bradycardia Arrhythmia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study |
- Model 4965 Complication Free Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
| Enrollment: | 73 |
| Study Start Date: | September 1996 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.
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)
Contacts and Locations
Show 107 Study Locations| Study Chair: | 4965 Post-Approval Study Clinical Trial Leader | Medtronic |
More Information
No publications provided
| Responsible Party: | Medtronic Cardiac Rhythm Disease Management |
| ClinicalTrials.gov Identifier: | NCT01076348 History of Changes |
| Other Study ID Numbers: | 4965 |
| Study First Received: | February 24, 2010 |
| Results First Received: | May 16, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Institutional Review Board Canada: Ethics Review Committee Australia: Human Research Ethics Committee Germany: Federal Institute for Drugs and Medical Devices Serbia and Montenegro: Agency for Drugs and Medicinal Devices Serbia: Ethics Committee Austria: Ethikkommission Denmark: Ethics Committee Switzerland: Swissmedic Switzerland: Ethikkommission Sweden: Regional Ethical Review Board Italy: Ethics Committee France: Conseil National de l'Ordre des Médecins |
Keywords provided by Medtronic Cardiac Rhythm Disease Management:
|
Epicardial Pacing Lead |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Failure Bradycardia |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013