CardioMEMS European Monitoring Study for Heart Failure

CardioMEMS European Monitoring Study for Heart Failure

The purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.

Inclusion Criteria:

• Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
• ≥ 18 years of age
• Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
• Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
• Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
• Written informed consent obtained from subject

Exclusion Criteria:

• Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
• Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up