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

SJ4 Post Approval Study

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 Overview

• Status: Completed
• Conditions: Heart Failure; Sudden Cardiac Death; Tachyarrhythmias
• Intervention / Treatment: Device: SJ4 connector and RV high voltage SJ4 lead

• Study Type: Observational
• Enrollment (Actual): 1701

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICD and CRTD indicated patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment: ICD/CRTD-indicated	Device: SJ4 connector and RV high voltage SJ4 lead; Standard of care implantation of SJ4 device system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Right Ventricle (RV) Bipolar Capture Thresholds	5 years
Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector	5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Bruce Wilkoff, MD, The Clevleland Clinic Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 16, 2009

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; ICD; CRTD; DF4
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Heart Failure; Death; Tachycardia; Death, Sudden, Cardiac
• Other Study ID Numbers: 60020938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO