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

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ClinicalTrials.gov Identifier: NCT00271180
Recruitment Status : Recruiting
First Posted : December 30, 2005
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief 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.

Condition or disease Intervention/treatment
Arrhythmia Bradycardia Heart Failure Sinus Tachycardia Device: Device

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

Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic CRDM Product Performance Report
Study Start Date : January 1983
Estimated Primary Completion Date : December 2040
Estimated Study Completion Date : December 2040



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects implanted with Medtronic qualifying cardiac rhythm product.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271180


Contacts
Contact: Medtronic CRM Clinical Trials medtroniccrmtrials@medtronic.com

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United Kingdom
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Sponsors and Collaborators
Medtronic
Investigators
Study Chair: Product Performance Report Study Leader Medtronic

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00271180     History of Changes
Other Study ID Numbers: 602
First Posted: December 30, 2005    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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

Keywords provided by Medtronic:
Cardiac Pacing
Implantable Cardioverter Defibrillator
pacemaker
Sinus Bradycardia

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Bradycardia
Tachycardia, Sinus
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Tachycardia, Supraventricular