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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00605631 |
This study is designed to evaluate the effect of pacing on post-MI patients.
Condition | Intervention |
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Post Myocardial Infarction |
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
Official Title: | The Prevention of Myocardial Enlargement and Dilatation Post Myocardial Infarction Study |
Estimated Enrollment: | 110 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
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2: Active Comparator |
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
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3 |
Device: Cardiac pacing using any Guidant/Boston Scientific Implantable ICD or CRT-D System and any Guidant/Boston Scientific Intracardiac Lead System
No specific device model is required - any FDA-approved, market-released Guidant/Boston Scientific implantable ICD or CRT-D system and any FDA-approved, market-released Guidant/Boston Scientific intracardiac lead system may be implanted as part of MENDMI.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Christ Hospital | |
Cincinnati, Ohio, United States, 45219 |
Principal Investigator: | Eugene Chung, MD | Christ Hospital Cincinnati |
Responsible Party: | Boston Scientific Corporation Cardiac Rhythm Management ( Douglas Daum, Ph.D./Director, Therapy Research ) |
Study ID Numbers: | MENDMI |
Study First Received: | December 20, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00605631 |
Health Authority: | United States: Food and Drug Administration |
Pacing |
Necrosis Hypertrophy Heart Diseases Dilatation, Pathologic Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |