CardioMEMS European Monitoring Study for Heart Failure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-03-01

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CardioMEMS HF System

Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications.

Group Type EXPERIMENTAL

CardioMEMS HF System

Intervention Type DEVICE

Pulmonary Artery Pressure Monitoring

Interventions

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CardioMEMS HF System

Pulmonary Artery Pressure Monitoring

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No