Post-Myocardial Infarction Remodeling Prevention Therapy (PRomPT)

Medtronic

Status and phase

Completed

Phase 2

Conditions

Pacing Therapy

Cardiac Remodeling

Heart Failure

Acute Myocardial Infarction

Treatments

Device: Single Site Pacing

Device: Dual Site Pacing

Study type

Interventional

Funder types

Industry

Identifiers

NCT01213251

PRomPT

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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