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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00271180
Recruitment Status : Recruiting
First Posted : December 30, 2005
Last Update Posted : November 21, 2018
Information provided by (Responsible Party):

December 28, 2005
December 30, 2005
November 21, 2018
January 1983
December 2040   (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). ]
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 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 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
Device: Device
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2040
December 2040   (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
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact: Medtronic CRM Clinical Trials
Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Iceland,   Israel,   Italy,   Japan,   Kuwait,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Saudi Arabia,   Serbia,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Australia,   Austria,   Finland,   Former Serbia and Montenegro
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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Study Chair: Product Performance Report Study Leader Medtronic
November 2018