Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products



Status:Recruiting
Conditions:Allergy, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Otolaryngology
Healthy:No
Age Range:Any
Updated:11/23/2018
Start Date:January 1983
End Date:December 2040
Contact:Medtronic CRM Clinical Trials
Email:medtroniccrmtrials@medtronic.com

Use our guide to learn which trials are right for you!

Medtronic CRDM Product Performance Report

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.

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are
eligible to be included in this study.

Subjects who meet the following inclusion criteria and do not meet any of the following
exclusion criteria are eligible for enrollment.

Inclusion Criteria:

• 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 Criteria:

- 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
We found this trial at
104
sites
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Clinton, MD
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Colorado Springs, Colorado 80910
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Raleigh, NC
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Rancho Mirage, California 90070
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Redwood City, CA
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Washington,
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West Des Moines, IA
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Wilkes-Barre, Pennsylvania 18711
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Wilkes-Barre, PA
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Winston-Salem, NC
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