Status:
RECRUITING
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Lead Sponsor:
Medtronic
Conditions:
Arrhythmia
Bradycardia
Eligibility:
All Genders
Brief Summary
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzi...
Detailed Description
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
Eligibility Criteria
Inclusion
- Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
- • Subject 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 must also apply:
- Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
- Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
Exclusion
- Subjects who are, or will be inaccessible for follow-up
- Subjects with exclusion criteria required by local law (EMEA only)
- Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
- Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
Key Trial Info
Start Date :
January 1 1983
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2040
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT00271180
Start Date
January 1 1983
End Date
December 1 2040
Last Update
December 17 2025
Active Locations (318)
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1
Birmingham, Alabama, United States
2
Anchorage, Alaska, United States
3
Chandler, Arizona, United States
4
Jonesboro, Arkansas, United States