Back to resultsD2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Primary Purpose
Heart Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator
Sponsored by
About this trial
This is an interventional treatment trial for Heart Diseases focused on measuring Sensing, Capture Management, Heart Failure, ICD Indication
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy
Secondary Outcome Measures
Full Information
NCT ID
NCT00328705
First Posted
May 19, 2006
Last Updated
February 11, 2008
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00328705
Brief Title
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Official Title
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
Sensing, Capture Management, Heart Failure, ICD Indication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator
Primary Outcome Measure Information:
Title
Ventricular fibrillation (VF) detection time
Title
Ventricular Capture Management accuracy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cole Hannon
Organizational Affiliation
Medtronic CRDM
Official's Role
Study Director
Facility Information:
City
Tampa
State/Province
Florida
Country
United States
City
Coon Rapids
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
St. Paul
State/Province
Minnesota
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
We'll reach out to this number within 24 hrs