This clinical study is designed to show that a multidisciplinary team following a pre-specified standard of care medication decision model based on data from an implanted cardioverter device will increase the rate of change in Guideline Directed Medical Therapy (GDMT) in the intervention group compared to the conventional group in patients with ischemic and non-ischemic cardiomyopathies.
Subjects in this study will be randomized (2:1) to an intervention group whose medical care will be guided by data from a cardiac implantable electronic device (CIED) including information on heart rate, activity, and fluid status derived from the OptiVol monitor versus a conventional management control group. Subjects will followed for 12 months with follow up contact for 6 consecutive months and a chart review at 12 months. The study population will include patients with ischemic and non-ischemic cardiomyopathy who have had an ICD implanted per standard of care guidelines.
18 to 85 years of age on the date of randomization ICD implantation per guidelines for primary prevention in patients with ischemic and non-ischemic cardiomyopathy ≥3 calendar months ago. SMART Phone or tablet with Bluetooth capability with internet access. No other identifiable reversible cause explaining the left ventricular dysfunction
Exclusion Criteria:
CRT implanted LVEF>45% in the last echocardiogram or other clinic imaging study performed. Medtronic device generator and/or device components not implanted Unstable clinical condition, life threatening arrhythmia Heart failure hospitalization within the preceding 3 calendar months Cognitive impairment Severe renal dysfunction (eGFR < 30 ml/min/m2) Serious known concomitant disease with a lift expectancy of < 12 calendar months Non-ambulatory NYHA class IV Pregnancy
