Lux Trends: LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study

Inclusion Criteria:

• Patient is currently in NYHA Class II or III.
• For patients with LVEF >40% measured on most recent available echocardiography within the previous 12 months:
• ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm AND
• ONE (1) of the following: Elevated BNP/NT-proBNP as defined by: BNP >100 pg/ml or NT-proBNP >300 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >300 pg/ml or NT-proBNP >900 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
• For patients with LVEF <40% (for MI patients, measured no less than 30 days post-MI) on most recent available echocardiography within the previous 12 months:
• ONE (1) of the following: Elevated BNP/NT-proBNP as defined by BNP >150 pg/ml or NT-proBNP >600 pg/ml within the previous 90 days for patients not in atrial fibrillation or BNP >450 pg/ml or NT-proBNP >1800 pg/ml for patients in atrial fibrillation at the time of screening for eligibility OR Documented heart failure hospitalization or unscheduled heart failure IV therapy in the previous 12 months
• Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
• Patient is of legal age to give informed consent and is willing to participate in the trial.

Exclusion Criteria:

• Patient is currently implanted with any other active electronic medical device.
• Patient has undergone a heart transplant.
• Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.
• Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.
• Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.