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Eligibility
for people ages 18 years and up
Location
at Sacramento, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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

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

  • Regional Cardiology Associates
    Sacramento, California, 95819, USA
  • Glendale Memorial Hospital and Medical Center
    Glendale, California, 91206, USA
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California, 90027, USA
  • University of California at San Diego (UCSD) Medical Center
    San Diego, California, 92118, USA
  • Claudio Bonometti MD, Inc
    Santa Barbara, California, 93105, USA
  • Los Angeles Biomedical Research Institute at Harbor-UCLA
    Torrance, California, 90502, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
St. Jude Medical
ID
NCT01179477
Phase
Phase 4
Lead Scientist
Nitish Badhwar
Study Type
Observational
Last Updated
July 2016