CardioMEMS HF System Coverage With Evidence Development Study

Recruiting now

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT06779552

Run by

Abbott Medical Devices

People needed

1000

Starts

2025-02-07

Expected to finish

2032-03-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
• Subject >=18 years of age at time of implant
• 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

You may not qualify if…

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

Where it is running

• Abbott — Pleasanton, California, United States (enrolling)

Full record on ClinicalTrials.gov

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