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

Recruiting now

Conditions studied: Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia

In brief

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.

Key facts

Study ID

NCT00271180

Run by

Medtronic

People needed

20000

Starts

1983-01-01

Expected to finish

2040-12-01

Last updated by the study team

2026-05-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Safety Harbor, Florida, United States (enrolling)
• Study site — Atlanta, Georgia, United States (enrolling)
• Study site — Clearwater, Florida, United States (enrolling)
• Study site — Panama City, Florida, United States (enrolling)
• Study site — Sarasota, Florida, United States (enrolling)
• Study site — Tampa, Florida, United States (enrolling)
• Study site — Washington D.C., District of Columbia, United States (enrolling)
• Study site — Birmingham, Alabama, United States (enrolling)
• Study site — Little Rock, Arkansas, United States (enrolling)
• Study site — Jacksonville, Florida, United States (enrolling)
• Study site — Chandler, Arizona, United States (enrolling)
• Study site — Salinas, California, United States (enrolling)
• Study site — Chula Vista, California, United States (enrolling)
• Study site — Stanford, California, United States (enrolling)
• Study site — Torrance, California, United States (enrolling)
• Study site — La Jolla, California, United States (enrolling)
• Study site — Ventura, California, United States (enrolling)
• Study site — Aurora, Colorado, United States (enrolling)
• Study site — Centennial, Colorado, United States (enrolling)
• Study site — Colorado Springs, Colorado, United States (enrolling)
• Study site — Hollywood, Florida, United States (enrolling)
• Study site — Lakewood, Colorado, United States (enrolling)
• Study site — Hartford, Connecticut, United States (enrolling)
• Study site — New Haven, Connecticut, United States (enrolling)
• Study site — Evansville, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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