RecruitingNCT06779552

CardioMEMS HF System Coverage with Evidence Development Study

Sponsor

Abbott Medical Devices

Enrollment

1,000 participants

Start Date

Feb 7, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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)