Health Condition 1: null- The study will enroll acute post MI patients with a reduced LVEF (â?¤35%) one day before or on the day of discharge from hospital after index MI. There is no control group in this study
Conditions
Interventions
Intervention1: NUVANT MCT system External Loop Recorder: The NUVANT MCT System consists primarily of the PiiX external monitoring patch, the zLink data transmission device and a Patient Trigger Magnet
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must provide written informed consent/data release consent to participate in the study. 2. Acute Myocardial Infarction (STEMI or non-STEMI) within the last 10 days based on ESC/ACC/AHA/WHF criteria (Thygesen, 2012) matching the following criteria: Rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: a. Symptoms of ischaemia. b. New or presumed new significant ST-segmentâ??T wave (STâ??T) changes or new left bundle branch block (LBBB). c. Development of pathological Q waves in the ECG. d. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. e. Identification of an intracoronary thrombus by angiography. 3. LVEF <=35% as measured by echocardiography (Simpsonâ??s method, biplane) one day before or on the day of hospital discharge
Exclusion criteria
Exclusion criteria: • Patients who cannot be discharged from the hospital within14 days after index Myocardial Infarction event • Age 18 years • Psychologically incapacitated • Patient is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion. • Patients contraindicated for NUVANT system • Comorbidities likely to limit survival to less than the minimal study duration (12 months) • Participation in an investigational study with known or suspected cardiac effect expected to confound the results of this study (e.g. stem cell trials, stent trials, cardiac intervention trials, drug trials) • Patients with an existing pacemaker or ICD implanted. • Patients that are dialysis dependent at discharge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?? Clinically significant arrhythmias reported by ELR at acute monitoring periodTimepoint: No specific Time point | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? Clinically significant arrhythmias reported by ELR at chronic (8-10 weeks post MI) monitoring period â?? ELR reported arrhythmia driven medical interventions or needs for medical interventions â?? All-cause mortality â?? Sudden cardiac death or resuscitated Ventricular Fibrillation or appropriate shockTimepoint: No specific Timepoint | — |
Countries
India
Contacts
Public ContactHaresh Sachanandani
India Medtronic Pvt. Ltd.
Outcome results
None listed