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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013