D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Inclusion Criteria:

• Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
• Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.

Exclusion Criteria:

• Patients who have 3rd degree heart block, as assessed by the investigator
• Patients who have a mechanical tricuspid heart valve
• Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device