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

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ClinicalTrials.gov Identifier: NCT00328705
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : February 13, 2008
Information provided by:

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

Condition or disease Intervention/treatment
Heart Diseases Device: Implantable Cardioverter Defibrillator

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  (Clinical Trial)
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 2006
Primary Completion Date : January 2007
Study Completion Date : January 2007
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Ventricular fibrillation (VF) detection time
  2. Ventricular Capture Management accuracy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328705

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 and Heart Failure
Study Director: Cole Hannon Medtronic CRDM
More Information

Responsible Party: Cole Hannon, CRDM clinical research
ClinicalTrials.gov Identifier: NCT00328705     History of Changes
Other Study ID Numbers: 209
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: February 13, 2008
Last Verified: February 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Capture Management
Heart Failure
ICD Indication

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases