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4968 Post-approval Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Medtronic Cardiac Rhythm Disease Management.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01076361
First received: February 24, 2010
Last updated: March 21, 2011
Last verified: March 2011
History of Changes
  Purpose

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Product Performance Platform (PPP).


Condition
Arrhythmia
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 4968 lead-related complications [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 1999
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects implanted with a 4968 lead.

Criteria

Inclusion Criteria:

  • Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board
  • Availability of implant, follow-up, and product-related event data
  • Implanted with a Model 4968 Capsure Epi Lead

Exclusion Criteria:

  • Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
  • Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center
  • Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
  • Subjects with exclusion criteria required by local law
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076361

Contacts
Contact: 4968 Clinical Trial Leader medtronicCRMtrials@medtronic.com

  Show 107 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: 4968 Clinical Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: 4968 Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT01076361     History of Changes
Other Study ID Numbers: 4968
Study First Received: February 24, 2010
Last Updated: March 21, 2011
Health Authority: 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 and Montenegro: 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:
Epicardial
Pacing Lead

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013