Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants.
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

Resource links provided by NLM:


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
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 April 23, 2014