System Longevity Study: Evaluating Reliability and Performance of Medtronic Cardiac Therapy Products (SLS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00271180
First received: December 28, 2005
Last updated: April 23, 2013
Last verified: April 2013

December 28, 2005
April 23, 2013
January 1983
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Lead related complications for each lead model. [ Time Frame: Ongoing: Implant to the cardiac lead is is out-of-service or patient has been exited from the study. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00271180 on ClinicalTrials.gov Archive Site
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System Longevity Study: Evaluating Reliability and Performance of Medtronic Cardiac Therapy Products
Medtronic System Longevity Study

The main purpose of the System Longevity Study is to evaluate long-term performance of Medtronic market-released cardiac therapy products by analyzing product survival probabilities. This study is part of the Product Performance Platform (PPP).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects implanted with Medtronic qualifying cardiac therapy product.

  • Arrhythmia
  • Bradycardia
  • Heart Failure
  • Sinus Tachycardia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15000
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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 to SLS
  • Subjects implanted with Medtronic CapSure Epi Leads (4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.

Exclusion Criteria:

  • Subjects who are, or will be inaccessible for follow-up at a SLS center
  • 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
Both
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No
Contact: Medtronic CRM Clinical Trials medtroniccrmtrials@medtronic.com
Austria,   Belgium,   Denmark,   France,   Germany,   Italy,   Netherlands,   Serbia,   Sweden,   Switzerland
 
NCT00271180
602
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
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Study Chair: System Longevity Study Leader Medtronic
Medtronic Cardiac Rhythm Disease Management
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP