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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00940888
First received: July 14, 2009
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • RV capture thresholds [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Complication free survival rate related to the high voltage RV SJ4 lead or SJ4 connector [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1700
Study Start Date: June 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICD and CRTD indicated patients

Criteria

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 ClinicalTrials.gov identifier: NCT00940888

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00940888     History of Changes
Other Study ID Numbers: 60020938
Study First Received: July 14, 2009
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
ICD
CRTD
Heart Failure
DF4

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on August 28, 2014