SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

Completed

Conditions studied: Tachyarrhythmias, Sudden Cardiac Death, Heart Failure

In brief

The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Key facts

Study ID

NCT00940888

Run by

Abbott Medical Devices

People needed

1701

Starts

2009-06-01

Expected to finish

2015-12-01

Last updated by the study team

2019-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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