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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00158925 |
The purpose of this study is to assess the safety and effectiveness of the EASYTRAK EPI lead.
Condition | Intervention | Phase |
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Bradycardia Congestive Heart Failure |
Device: EASYTRAK EPI lead |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The EASYTRAK EPI Clinical Investigation |
Enrollment: | 100 |
Study Start Date: | September 2004 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet any one of the following three conditions:
Exclusion Criteria:
United States, Minnesota | |
Multiple Locations in the US | |
St. Paul, Minnesota, United States |
Principal Investigator: | Daniel Beckman, MD | The Methodist Hospital System |
Responsible Party: | Boston Scientific ( Steven McQuillan, Director of Clinical Affairs ) |
Study ID Numbers: | Clinicals0001, EASYTRAK EPI |
Study First Received: | September 8, 2005 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00158925 |
Health Authority: | United States: Food and Drug Administration |
Artificial Cardiac Pacing Implanted Electrodes |
Heart Failure Heart Diseases Bradycardia Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |