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

This study has been completed.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure Identifier:
First received: May 19, 2006
Last updated: February 11, 2008
Last verified: February 2008
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Condition Intervention
Heart Diseases
Device: Implantable Cardioverter Defibrillator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00328705     History of Changes
Other Study ID Numbers: 209
Study First Received: May 19, 2006
Last Updated: February 11, 2008

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017