CardioMEMS European Monitoring Study for Heart Failure

Not Applicable

Completed

Conditions: Heart Failure

Interventions: Device: CardioMEMS HF System

Registration Number: NCT02693691

Lead Sponsor: Abbott Medical Devices

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 239

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CardioMEMS HF System	CardioMEMS HF System	Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.

Primary Outcome Measures

Name	Time	Method
Freedom From Device/System Related Complications	one year	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.
Percent of Successful Pulmonary Artery Pressure Data Transmissions	one year	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.
Freedom From Pressure Sensor Failure	one year	This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant.

Secondary Outcome Measures

Name	Time	Method
Heart Failure Hospitalization (HFH) Rate	one year	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.