SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Completed
- Conditions
- Heart FailureTachyarrhythmiasSudden Cardiac Death
- Interventions
- Device: SJ4 connector and RV high voltage SJ4 lead
- Registration Number
- NCT00940888
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1701
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No treatment: ICD/CRTD-indicated SJ4 connector and RV high voltage SJ4 lead -
- Primary Outcome Measures
Name Time Method Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector 5 years Right Ventricle (RV) Bipolar Capture Thresholds 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States