Status:
COMPLETED
QuickFlex Micro Left Ventricular Lead Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.
Detailed Description
The primary endpoints of the study are: * Freedom from LV lead-related complications at 5 years * LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 ...
Eligibility Criteria
Inclusion
- Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
1930 Patients enrolled
Trial Details
Trial ID
NCT01179477
Start Date
September 1 2010
End Date
September 1 2017
Last Update
August 12 2019
Active Locations (77)
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1
Cardiovascular Associates P.C.
Birmingham, Alabama, United States, 35213
2
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35294
3
Heart Center Research, LLC.
Huntsville, Alabama, United States, 35801
4
Alaska Heart Institute
Anchorage, Alaska, United States, 99508