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

This study has been completed.

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00328705

Purpose

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

Condition	Intervention
Heart Diseases	Device: Implantable Cardioverter Defibrillator

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy

Enrollment:	65
Study Start Date:	May 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328705

Locations

United States, Florida

Tampa, Florida, United States
United States, Minnesota

Coon Rapids, Minnesota, United States

Rochester, Minnesota, United States

St. Paul, Minnesota, United States
United States, North Carolina

Charlotte, North Carolina, United States

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Study Director:

Cole Hannon

Medtronic CRDM

More Information

Responsible Party:	CRDM clinical research ( Cole Hannon )
Study ID Numbers:	209
Study First Received:	May 19, 2006
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00328705
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Sensing
Capture Management
Heart Failure
ICD Indication

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009