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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 Optim™ 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 Optim™ 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

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