Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study
This study has been completed.
Information provided by (Responsible Party):
First received: February 24, 2010
Last updated: October 24, 2014
Last verified: October 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:
||Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects implanted with a 4968 lead.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076361
||4968 Clinical Trial Leader
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 24, 2010
|Results First Received:
||June 28, 2013
||October 24, 2014
||United States: Institutional Review Board
Canada: Ethics Review Committee
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Denmark: Ethics Committee
Sweden: Regional Ethical Review Board
Italy: Ethics Committee
Australia: Human Research Ethics Committee
Keywords provided by Medtronic:
ClinicalTrials.gov processed this record on July 01, 2015