Clinical Trials

Inclusion Criteria:

Cohort A

• Subjects without diagnosis of cardiovascular disease, including coronary artery disease, myocardial infarction and heart failure.
• Age 18 years or older on the day of screening.
• Agreeable to wear the WCD.

Cohort B

• Subjects with history of heart failure and at least one prevoius heart failure hospitalization.
• Age 18 years or older on the day of screening.
• Agreeable to wear the WCD.

Exclusion Criteria:

Absolute Contraindication to Exercise Testing

• Acute myocardial infarction (within 2 days).
• Unstable angina not previously stabilized by medical therapy.
• Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
• Symptomatic severe aortic stenosis.
• Uncontrolled symptomatic heart failure.
• Acute pulmonary embolus or pulmonary infarction.
• Acute myocarditis or pericarditis.
• Acute aortic dissection.

Relative Contraindication to Exercise Testing

• Left main coronary stenosis.
• Moderate stenotic valvuar heart disease.
• Electrolyte abnormalities.
• Severe arterial hypertension.
• Tachyarrhythmias or bradyarrhythmias.
• Hypertrophic cardiomyopathy and other forms of outflow tract obstruction.
• Mental or physical impairment leading to inability to exercise adequately.
• High-degree atrioventricular block.
• Advance or complicated pregnancy.

Other Reasons for Exclusion

• Subjects with a pacemaker dependent rhythm, including implanted pacemaker or CRT.
• Subjects having a chest circumference over 56 inches (142 cm) or under 26 inches (66 cm).
• Subjects unable or unwilling to provide informed consent.