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

Abbott Medical Devices1,701 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,701

Conditions

Tachyarrhythmias Sudden Cardiac Death Heart Failure

Interventions

SJ4 connector and RV high voltage SJ4 leadDEVICE

Standard of care implantation of SJ4 device system

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Right Ventricle (RV) Bipolar Capture Thresholds

Time frame: 5 years

Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector

Time frame: 5 years

Data from ClinicalTrials.gov

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