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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 12, 2014
Last verified: September 2014

December 28, 2005
September 12, 2014
January 1983
December 2024   (final data collection date for primary outcome measure)
Lead related complications for each lead model. [ Time Frame: Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive). ] [ Designated as safety issue: No ]
All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.
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Complete list of historical versions of study NCT00271180 on ClinicalTrials.gov Archive Site
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Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
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.

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

Subjects implanted with Medtronic qualifying cardiac rhythm 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
December 2024
December 2024   (final data collection date for primary outcome measure)

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
Both
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No
Contact: Medtronic CRM Clinical Trials medtroniccrmtrials@medtronic.com
United States,   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: Product Performance Report Study Leader Medtronic
Medtronic Cardiac Rhythm Disease Management
September 2014

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