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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1701 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Tachyarrhythmias Sudden Cardiac Death Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment: ICD/CRTD-indicated

SJ4 connector and RV high voltage SJ4 lead

Intervention Type DEVICE

Standard of care implantation of SJ4 device system

Interventions

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SJ4 connector and RV high voltage SJ4 lead

Standard of care implantation of SJ4 device system

Intervention Type DEVICE

Eligibility Criteria

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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.
* Be less than 18 years of age.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No