Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01213251
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01213251
Study Brief:
Protocol Section:
NCT01213251