Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boston Scientific Corporation |
---|---|
Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00158938 |
The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead
Condition | Intervention | Phase |
---|---|---|
Congestive Heart Failure |
Device: EASYTRAK 3 left ventricular pacing lead |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead |
Estimated Enrollment: | 115 |
Study Start Date: | May 2003 |
Study Completion Date: | November 2004 |
This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Clinicals0007 |
Study First Received: | September 8, 2005 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00158938 |
Health Authority: | United States: Food and Drug Administration |
Artificial Cardiac Pacemaker Implanted Electrodes |
Heart Failure Heart Diseases |
Cardiovascular Diseases |