CardioMEMS European Monitoring Study for Heart Failure

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

Official Title
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CardioMEMS European Monitoring Study for Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CardioMEMS HF System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CardioMEMS HF System<br>Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. | Device: CardioMEMS HF System<br>* Pulmonary Artery Pressure Monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Device/System Related Complications | This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant. | one year | 
| Freedom From Pressure Sensor Failure | This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant. | one year | 
| Percent of Successful Pulmonary Artery Pressure Data Transmissions | Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Hospitalization (HFH) Rate | Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant. | one year |