Post-Myocardial Infarction Remodeling Prevention Therapy



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:December 2010
Contact:Marina Ostanniy
Email:rs.prompt@medtronic.com
Phone:(763) 526-9751

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The purpose of this study is to demonstrate the feasibility of pacing as a therapy to
prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI)
in patients at highest risk for adverse myocardial remodeling.


Inclusion Criteria:

- MI within the past 10 days

- Peak CPK greater than 3000 Units/Litre (U/L) at time of MI, or a troponin T (TnT)
greater than 10 micrograms/Litre (mcg/L)

- At least 18 years old

- Willing to comply with the protocol

Exclusion Criteria:

- Documented MI greater than 10 days

- Chronic renal disease, as defined by estimated glomerular filtration rate (eGFR) less
than 30 milliliters/minute/1.73 square meter

- Life expectancy less than 18 months, as determined by a physician

- Existing pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac
Resynchronization Therapy (CRT) device

- QRS duration greater than 120 milliseconds (ms)

- Coronary Artery Bypass Graft (CABG) within 30 days prior to MI, or CABG procedure
planned

- Third degree atrioventricular (AV) block or symptomatic bradyarrhythmia

- Persistent atrial fibrillation (AF) that is not self terminating within 7 days or is
terminated electrically or pharmacologically

- Permanent AF that is non self terminating, with cardioversion failed or not attempted
within the past year

- NYHA Class IV

- Non-ischemic cardiomyopathy

- Pregnant or planning to become pregnant during the study

- Enrolled or planning to participate in a concurrent drug and/or device study during
the course of this clinical trial. Co-enrollment in concurrent trials is only allowed
with documented pre-approval from Medtronic, documenting that there is not a concern
that co-enrollment could confound the results of this trial.

- Breast feeding

- Of a vulnerable population as determined by local law or requirement, or a physician
We found this trial at
17
sites
Houston, Texas 77004
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Ann Arbor, Michigan 48106
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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Chattanooga, Tennessee 37404
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Cincinnati, Ohio 45219
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Dallas, TX
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Gastonia, North Carolina 28054
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Germantown, Tennessee 38138
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Lexington, Kentucky 40503
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Nashville, Tennessee 37205
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Scottsdale, Arizona 85251
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Spokane, Washington 99204
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Vallejo, California 94589
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Vallejo, CA
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