OPTIMUM
Objective
Status: Enrollment complete
Condition: Cardiac device
Description
To evaluate the clinical performance of the leads used during pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implants.
Purpose
The purpose of the registry is to evaluate the clinical performance of the St. Jude lead. Information from the St. Jude Optimâ„¢ device will be collected by using a computer programmer. This information may change the way persons are treated in the future by improving the leads used during pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implants in the future.
Phase
Registry
Key Inclusion Criteria
Patients whom have been prescribed a St. Jude Optimâ„¢ lead for their pacemaker, ICD or CRT-D.
Key Exclusion Criteria
Use of other lead for pacemaker, ICD or CRT-D.
ClinicalTrials.gov Identifier
NA
IRB Protocol Number
060605 CRD 336
Principal Investigator(s)
Rabeea Aboufakher, MD
Sponsor(s)
St. Jude Medical
Contact
Brenda Westacott, CCRC at 701.780.1845 or bwestacott@altru.org