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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure (Industry)

Overall Status

Completed

CT.gov ID

NCT00328705

Collaborator

Medtronic (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	Device: Implantable Cardioverter Defibrillator	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Ventricular fibrillation (VF) detection time []
Ventricular Capture Management accuracy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Tampa	Florida	United States
2	Coon Rapids	Minnesota	United States
3	Rochester	Minnesota	United States
4	St. Paul	Minnesota	United States
5	Charlotte	North Carolina	United States