Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01361672
First received: May 25, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to evaluate long-term performance of the 4296 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4296 LV Lead. This study is part of the Product Performance Platform (PPP).


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain Ability® Family Left Ventricular Lead Chronic Performance Study

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

Primary Outcome Measures:
  • Model 4296 LV Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Types of lead-related adverse device effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of fractures with and without loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Bipolar electrical performance at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bipolar pacing impedance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bipolar pacing capture threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1016
Study Start Date: May 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Detailed Description:

Lead survivability will be summarized.

  Eligibility

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

Patients implanted with a 4296 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject or appropriate legal guardian provides written informed consent and authorization for access to and use of health information (if applicable).
  • Complete implant and follow-up data, including Model 4296 lead-related events are available.

AND one of the following must apply:

  • Subject is within 30 days post-implant of a 4296 Model lead connected to a market released Cardiac Resynchronization Therapy (Cardiac Resynchronization Therapy-Pacemaker or Cardiac Resynchronization Therapy-Defibrillator) device. The Medtronic lead must be used for a pacing or sensing application.
  • Subject who participated in the Medtronic Attain Ability Model 4296 Left Ventricular Lead Pre-Market Study.

Exclusion Criteria:

  • Subject implanted at a non-participating site, and implant, follow-up data, including Model 4296 lead-related events are not available within 30 days from implant.
  • Subject who is, or will be inaccessible for follow-up at a study site.
  • Subject with exclusion criteria required by local law (Europe, Middle East or Africa 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: NCT01361672

Contacts
Contact: Attain Ability Family LV Lead Chronic Performance Team rs.systemlongevitystudy@medtronic.com

  Show 113 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01361672     History of Changes
Other Study ID Numbers: 4296 Chronic Performance
Study First Received: May 25, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Italy: Ethics Committee
Denmark: Ethics Committee
France: Conseil National de l'Ordre des Médecins
Austria: Ethikkommission

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014