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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01076361
First Posted: February 26, 2010
Last Update Posted: January 23, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic
  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. ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT01076361


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

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01076361     History of Changes
Other Study ID Numbers: 4968
First Submitted: February 24, 2010
First Posted: February 26, 2010
Results First Submitted: June 28, 2013
Results First Posted: October 27, 2014
Last Update Posted: January 23, 2015
Last Verified: October 2014

Keywords provided by Medtronic:
Epicardial
Pacing Lead

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases