D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
Not Applicable
Completed
- Conditions
- Heart Diseases
- Registration Number
- NCT00328705
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Ventricular fibrillation (VF) detection time Ventricular Capture Management accuracy
- Secondary Outcome Measures
Name Time Method