Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

Official Title: “Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Study”

The purpose of this study is to evaluate long-term performance of the 4196 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 4196 LV Lead. This study is part of the Product Performance Platform (PPP).

Lead survivability will be summarized.

Primary Measures

• Lead-related complication rate
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Types of lead-related events
  • Time Frame: 5 years
    Safety Issue?: No
• Percent of subjects with changes in electrode programming
  • Time Frame: 5 Years
    Safety Issue?: No
• Percent of fractures with loss of function
  • Time Frame: 5 years
    Safety Issue?: No
• Mean bipolar pacing threshold
  • Time Frame: 1 year
    Safety Issue?: No
• Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations
  • Time Frame: 1 year
    Safety Issue?: No

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 4196 lead-related events are available.

AND one of the following must apply:

• Subject is within six months post-implant of a 4196 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 4196 Left Ventricular
• Lead Pre-Market Study.

Exclusion Criteria:

• Subject implanted at a non-participating site, and implant, follow-up data, including
• Model 4196 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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medtronic Cardiac Rhythm Disease Management Industry

Overall Clinical Trial Officials and Contacts

4196 LV Lead Chronic Performance Study Team Study Chair Medtronic  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930904

Study ID Number: 4196 Chronic Performance

ClinicalTrials.gov Identifier: NCT00930904

Health Authority: United States: Food and Drug Administration