SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | June 2009 |
| End Date: | December 2015 |
SJ4 Post Approval Study
The purpose of this study is to characterize the chronic performance of the St. Jude Medical
SJ4 connector and RV high voltage SJ4 leads.
SJ4 connector and RV high voltage SJ4 leads.
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.
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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