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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940888
Recruitment Status : Completed
First Posted : July 16, 2009
Results First Posted : August 14, 2017
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment
Tachyarrhythmias Sudden Cardiac Death Heart Failure Device: SJ4 connector and RV high voltage SJ4 lead

Study Type : Observational
Actual Enrollment : 1701 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SJ4 Post Approval Study
Study Start Date : June 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

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

Primary Outcome Measures :
  1. Right Ventricle (RV) Bipolar Capture Thresholds [ Time Frame: 5 years ]
  2. Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: St. Jude Medical Identifier: NCT00940888     History of Changes
Other Study ID Numbers: 60020938
First Posted: July 16, 2009    Key Record Dates
Results First Posted: August 14, 2017
Last Update Posted: December 5, 2017
Last Verified: May 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