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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Heart / Lead Placement
Title   Long Term Data Collection on Left Ventricular Lead Placement of Medtronics Model 4196 and 4296 (Heart / Lead Placement)
Description   This study is intended to confirm the long-term reliability of the Left Ventricular lead Model 4196 and 4296. Medtronic, Inc is sponsoring the Attain Ability Family Post Approval study which is partially integrated into the Product Performance Platform (PPP). Subjects on this study will have already had surgery to implant either the 4196 or 4296 lead (an insulated wire that carries the electrical impulse from the cardiac device to the heart). Subjects will be followed from their implant date for a minimum of 5 years.
IRB Number   Pro2779
Inclusion/Notes   INCLUSION:
  • Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.

  • Subject is implanted or is intended to be implanted with at least one Medtronic market-released product used for pacing, sensing or defibrillation application.

  • Subject within 30 days of implant or subject participated in the pre-market study phase for the product now enrolling in the PPP in which case the subject can be enrolled retrospectively (implant day is defined as day 0).

EXCLUSION:
  • Subject who is, or will be inaccessible for follow-up at site.

  • Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only).

  • Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable (Section 3.5.1 details minimum data requirements for eligibility).

  • Subject implanted with Medtronic market-released product but all implanted products are
    closed to enrollment per the Enrollment Guide
Status   Recruiting
Location   Texas Health Resources Arlington Tower
Principal Name    Kenneth Wade McBride MD
Contact Name   Anne Gilbert
Phone   (817) 420-4964

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