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

Medtronic

Status

Completed

Conditions

Heart Diseases

Treatments

Device: Implantable Cardioverter Defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328705

209

Details and patient eligibility

About

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

Full description

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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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