CardioMEMS HF System Coverage with Evidence Development Study

Abbott

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: CardioMEMS HF System

Study type: Observational

Funder types: Industry

Identifiers

NCT06779552

CL1027482

Details and patient eligibility

About

The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.

Full description

The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
2. Subject >=18 years of age at time of implant
3. Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP

Exclusion criteria

1. Subject has history of heart transplant or durable mechanical circulatory device
2. Subject hospitalized with cardiogenic shock or sepsis
3. Subject received prior PA pressure sensor implant (control arm only)

Trial design

1,000 participants in 2 patient groups

Treatment Group

Description:

Heart failure patients implanted with the CardioMEMS PA pressure sensor.

Treatment:

Device: CardioMEMS HF System

Control Group

Description:

Heart failure patients being managed without PA pressure-monitoring.