RecruitingNCT00271180
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Medtronic CRDM Product Performance Report
Sponsor
Medtronic
Enrollment
20,000 participants
Start Date
Jan 1, 1983
Study Type
OBSERVATIONAL
Conditions
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 analyzing product survival probabilities.
Eligibility
Inclusion Criteria4
- • 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 Criteria3
- Subjects who are, or will be inaccessible for follow-up
- 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
Interventions
DEVICEDevice
Locations(318)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT00271180
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