Model 4965 Post-Approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01076348
First received: February 24, 2010
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).


Condition
Heart Failure
Pacing
Bradycardia
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Model 4965 Complication Free Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.


Enrollment: 73
Study Start Date: September 1996
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.

Criteria

Inclusion Criteria:

  • Subjects 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 (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:

  • product is market-released
  • complete implant and follow-up data, including product-related adverse events, are available
  • subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.

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 SLS 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 (EMEA only)
  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: NCT01076348

  Show 107 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: 4965 Post-Approval Study Clinical Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01076348     History of Changes
Other Study ID Numbers: 4965
Study First Received: February 24, 2010
Results First Received: May 16, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee
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
France: Conseil National de l'Ordre des Médecins

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Epicardial
Pacing Lead

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

ClinicalTrials.gov processed this record on July 24, 2014