Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular lead.

Official Title

QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

Details

The endpoints of the study are:

  • Complication free survival rate at 5 years for complications related to the LV lead
  • Electrical performance (capture threshold) of St. Jude Medical's QuickFlex®µ 1258T LV Lead

Keywords

Heart Failure Left heart pacing lead Cardiac resynchronization therapy (CRT) Menthol Implantation of a QuickFlex® μ Model 1258T LV Lead

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T IDE study
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations

You CAN'T join if...

  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Have a life expectancy of less than 5 years due to any condition
  • Be less than 18 years of age

Locations

  • University of California at San Diego (UCSD) Medical Center
    San Diego California 92118 United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA
    Torrance California 90502 United States
  • Glendale Memorial Hospital and Medical Center
    Glendale California 91206 United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles California 90027 United States
  • Claudio Bonometti MD, Inc
    Santa Barbara California 93105 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
St. Jude Medical
ID
NCT01179477
Study Type
Observational
Last Updated
July 2016