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

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: July 14, 2009
Last updated: May 2, 2017
Last verified: May 2017
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.

Condition Intervention
Tachyarrhythmias Sudden Cardiac Death Heart Failure Device: SJ4 connector and RV high voltage SJ4 lead

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SJ4 Post Approval Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1701
Study Start Date: June 2009
Study Completion Date: December 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment: ICD/CRTD-indicated Device: SJ4 connector and RV high voltage SJ4 lead
Standard of care implantation of SJ4 device system


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICD and CRTD indicated patients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00940888

United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Bruce Wilkoff, MD The Clevleland Clinic Foundation
  More Information

Responsible Party: St. Jude Medical Identifier: NCT00940888     History of Changes
Other Study ID Numbers: 60020938
Study First Received: July 14, 2009
Results First Received: January 12, 2017
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden
Arrhythmias, Cardiac processed this record on August 16, 2017