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CardioMEMS HF System Coverage With Evidence Development Study

Who can join

Ages 18 and older · All sexes

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)

About the study

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.

What is being tested

• CardioMEMS HF System (device)

Sponsor: Abbott Medical Devices · Participants: 1,000 · Started: Feb 7, 2025

Contact the study team

• Nessa Johnson · Phone: 612-283-3865

Official record on ClinicalTrials.gov — NCT06779552

Locations in the U.S.

Conditions

• Heart Failure

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.