CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF)

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: CardioMEMS HF System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02693691

SJM-CIP-10105

Details and patient eligibility

About

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

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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239 participants in 1 patient group

CardioMEMS HF System

Experimental group

Description:

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

Treatment:

Device: CardioMEMS HF System