Status:

COMPLETED

Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

Lead Sponsor:

Medtronic

Conditions:

Heart Failure

Eligibility:

All Genders

Brief Summary

Lead survivability will be summarized.

Detailed Description

The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. This evaluation is based on the number of lead-related complications occurring during the study compare...

Eligibility Criteria

Inclusion

  • Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.
  • Inclusion Criteria
  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain Performa™ LV lead
  • Patient within 30 day post implant enrollment window
  • Exclusion Criteria
  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Exclusion

    Key Trial Info

    Start Date :

    August 1 2014

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    July 31 2021

    Estimated Enrollment :

    1900 Patients enrolled

    Trial Details

    Trial ID

    NCT02294331

    Start Date

    August 1 2014

    End Date

    July 31 2021

    Last Update

    February 1 2022

    Active Locations (100)

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    Page 1 of 25 (100 locations)

    1

    Birmingham, Alabama, United States, 35294

    2

    Anchorage, Alaska, United States, 99508

    3

    Chandler, Arizona, United States, 85226

    4

    Gilbert, Arizona, United States, 85295