Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic
ClinicalTrials.gov Identifier:
NCT01076361
First received: February 24, 2010
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.


Condition
Arrhythmia
Heart Failure

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Survival Probability of the Model 4968 Lead Based on Lead-related Complications [ Time Frame: The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety. ] [ Designated as safety issue: No ]
    The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability.


Enrollment: 370
Study Start Date: September 1999
Study Completion Date: September 2010
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
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: NCT01076361

  Show 106 Study Locations
Sponsors and Collaborators
Medtronic
Investigators
Study Chair: 4968 Clinical Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01076361     History of Changes
Other Study ID Numbers: 4968
Study First Received: February 24, 2010
Results First Received: June 28, 2013
Last Updated: October 24, 2014
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:
Epicardial
Pacing Lead

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014