Status:
COMPLETED
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tachyarrhythmias
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
Eligibility Criteria
Inclusion
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
- Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.
Exclusion
- Be currently participating in a clinical investigation that includes an active treatment arm.
- Have a life expectancy of less than 6 months due to any condition.
- Be less than 18 years of age.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
1701 Patients enrolled
Trial Details
Trial ID
NCT00940888
Start Date
June 1 2009
End Date
December 1 2015
Last Update
February 4 2019
Active Locations (1)
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1
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195