Post-Myocardial Infarction Remodeling Prevention Therapy

Post-Myocardial Infarction Remodeling Prevention Therapy

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:

• 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 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
• 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