Status:
COMPLETED
Post-Myocardial Infarction Remodeling Prevention Therapy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Acute Myocardial Infarction
Pacing Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Myocardial Infarction (MI) within the past 10 days
- Peak Creatine Phosphokinase (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
- 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
- New York Heart Association (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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01213251
Start Date
December 1 2010
End Date
April 1 2016
Last Update
December 15 2016
Active Locations (26)
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1
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
2
Kaiser Permanente
Los Angeles, California, United States, 90027
3
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
4
Lexington Cardiac Research Foundation
Lexington, Kentucky, United States, 40503