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

Heart Failure Clinical Trial

Official title:

SJ4 Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940888
• Other study ID #: 60020938
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1701
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death
• Tachyarrhythmias
• Tachycardia

Intervention

Device:
• SJ4 connector and RV high voltage SJ4 lead
Standard of care implantation of SJ4 device system

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right Ventricle (RV) Bipolar Capture Thresholds		5 years
Primary	Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector		5 years