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

NCT00271180

RecruitingN/A

Sponsor: Medtronic

Conditions: Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia

Interventions: Device

Countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, Denmark

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (333)
  • Birmingham, Alabama, United States
  • Anchorage, Alaska, United States
  • Chandler, Arizona, United States
  • Jonesboro, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Bakersfield, California, United States
  • Chula Vista, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Palm Springs, California, United States
  • Rancho Mirage, California, United States
  • Redwood City, California, United States
  • Salinas, California, United States
  • San Diego, California, United States
  • Stanford, California, United States
  • Torrance, California, United States
  • Van Nuys, California, United States
  • Ventura, California, United States
  • Aurora, Colorado, United States
  • Centennial, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Lakewood, Colorado, United States
  • Hartford, Connecticut, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Bradenton, Florida, United States
  • Clearwater, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • + 303 more on CT.gov