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
  Purpose

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
Arrhythmia
Bradycardia
Heart Failure
Sinus Tachycardia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medtronic CRDM Product Performance Report

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 15000
Study Start Date: January 1983
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271180

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

Locations
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States
Austria
Recruiting
Linz, Austria
Belgium
Recruiting
Hasselt, Belgium
Denmark
Recruiting
Copenhagen, Denmark
Recruiting
Kobenhavn, Denmark
France
Recruiting
Marseille, France
Recruiting
Nantes, France
Germany
Recruiting
Homburg/Saar, Germany
Italy
Recruiting
Reggio Emilia, Italy
Recruiting
Udine, Italy
Netherlands
Recruiting
Eindhoven, Netherlands
Recruiting
Rotterdam, Netherlands
Serbia
Recruiting
Beograd, Serbia
Sweden
Recruiting
Skovde, Sweden
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: Product Performance Report Study Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00271180     History of Changes
Other Study ID Numbers: 602
Study First Received: December 28, 2005
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Serbia: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Austria: Ethikkommission
Denmark: Ethics Committee
Switzerland: Swissmedic
Switzerland: Ethikkommission
Sweden: Regional Ethical Review Board
Italy: Ethics Committee
Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014