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

This study has been completed.

Sponsor:

Collaborator:

Medtronic

Information provided by:

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT00328705

First received: May 19, 2006

Last updated: February 11, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 19, 2006

Last Updated Date

February 11, 2008

Start Date ^ICMJE

May 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy

Original Primary Outcome Measures ^ICMJE

VF detection time
Ventricular Capture Management accuracy.

Change History

Complete list of historical versions of study NCT00328705 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Diseases

Intervention ^ICMJE

Device: Implantable Cardioverter Defibrillator

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00328705

Other Study ID Numbers ^ICMJE

209

Has Data Monitoring Committee

Responsible Party

Cole Hannon, CRDM clinical research

Study Sponsor ^ICMJE

Medtronic Cardiac Rhythm Disease Management

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Study Director:

Cole Hannon

Medtronic CRDM

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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