Heart Failure Clinical Trial
OptiVol for Precision Medical Management of Heart Failure
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
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
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