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Sponsored by: |
Boston Scientific Corporation |
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00384722 |
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
Condition | Intervention | Phase |
Heart Failure |
Device: EASYTRAK 3 Downsize Lead |
Phase II Phase III |
MedlinePlus related topics: | Heart Failure |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | EASYTRAK® 3 Downsize Lead Clinical Investigation |
Enrollment: | 70 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | May 2008 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |||||
Multiple Locations | |||||
St. Paul, Minnesota, United States, 55112 |
Boston Scientific Corporation |
Principal Investigator: | John Hummel, MD | Riverside Methodist Hospital |
Heart Failure 
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Responsible Party: | Boston Scientific ( Steven McQuillan, Director of Clinical Affairs ) |
Study ID Numbers: | Clinicals0011 |
First Received: | October 3, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00384722 |
Health Authority: | United States: Food and Drug Administration |
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