Status:
COMPLETED
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00328705
Start Date
May 1 2006
End Date
January 1 2007
Last Update
February 13 2008
Active Locations (5)
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1
Tampa, Florida, United States
2
Coon Rapids, Minnesota, United States
3
Rochester, Minnesota, United States
4
Saint Paul, Minnesota, United States