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

Abbott

Status: Completed

Conditions: Heart Failure; Sudden Cardiac Death; Tachyarrhythmias

Treatments: Device: SJ4 connector and RV high voltage SJ4 lead

Study type: Observational

Funder types: Industry

Identifiers

NCT00940888

60020938

Details and patient eligibility

About

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

Enrollment: 1,701 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,701 participants in 1 patient group

No treatment: ICD/CRTD-indicated

Treatment:

Device: SJ4 connector and RV high voltage SJ4 lead