N/A
N=1,701
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
Tachyarrhythmias · Sudden Cardiac Death · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00940888 ↗Enrolled (actual)
1,701
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Right Ventricle (RV) Bipolar Capture Thresholds — 0.92 Volts
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- SJ4 connector and RV high voltage SJ4 lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Right Ventricle (RV) Bipolar Capture Thresholds |
0.92 | — |
| PRIMARY Complication Free Survival Rate Related to the High Voltage RV SJ4 Lead or SJ4 Connector |
96.4 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00940888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.