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Sponsors and Collaborators: |
Medtronic Cardiac Rhythm Disease Management Medtronic |
Information provided by: | Medtronic Cardiac Rhythm Disease Management |
ClinicalTrials.gov Identifier: | NCT00328705 |
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
Condition | Intervention |
Heart Diseases |
Device: Implantable Cardioverter Defibrillator |
MedlinePlus related topics: | Heart Diseases |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management |
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) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Medtronic Cardiac Rhythm Disease Management |
Medtronic |
Study Director: | Cole Hannon | Medtronic CRDM |
Responsible Party: | CRDM clinical research ( Cole Hannon ) |
Study ID Numbers: | 209 |
First Received: | May 19, 2006 |
Last Updated: | February 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00328705 |
Health Authority: | United States: Food and Drug Administration |
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