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Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Medtronic CRDM Product Performance Report

Details

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

Keywords

Arrhythmia Bradycardia Heart Failure Sinus Tachycardia Cardiac Pacing Implantable Cardioverter Defibrillator pacemaker Sinus Bradycardia Tachycardia Tachycardia, Sinus

Eligibility

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

  • San Francisco, California, 94143, United States
  • Redwood City, California, 94062, United States
  • Stanford, California, 94305, United States
  • Salinas, California, 93901, United States
  • Bakersfield, California, 93301, United States
  • Bakersfield, California, 93309, United States
  • Van Nuys, California, 91405, United States
  • Los Angeles, California, 90048, United States
  • Torrance, California, 90505, United States
  • Henderson, Nevada, 89052, United States
  • Rancho Mirage, California, 92270, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT00271180
Study Type
Observational
Last Updated
November 29, 2017
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