CompletedInterventionalNot ApplicableUpdated Feb 4, 2019
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients | NCT00940888 | Trialant
CompletedObservationalUpdated Feb 4, 2019
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
SJ4 Post Approval Study
ClinicalTrials.gov ID
NCT00940888
Lead Sponsor
Abbott Medical DevicesINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
1,701Actual
Last Update Posted
Feb 4, 2019Actual
Start Date
Jun 2009
Primary Completion Date
Sep 2015Actual
Completion Date
Dec 2015Actual
Official Title
SJ4 Post Approval Study
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.
Tachyarrhythmias
Sudden Cardiac Death
Heart Failure
SJ4 connector and RV high voltage SJ4 lead
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.