Summary

at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Lead survivability will be summarized.

Official Title

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Details

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 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.

Keywords

Heart Failure Attain Performa™ LV Leads

Eligibility

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

Locations

  • San Francisco California 94143 United States
  • Redwood City California 94062 United States
  • Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic
ID
NCT02294331
Study Type
Observational
Last Updated
October 4, 2017