NCT06779552Recruiting
CardioMEMS HF System Coverage With Evidence Development Study
Abbott Medical Devices
Start Date
2/7/2025
Completion Date
3/1/2032
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to No maximum
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)
Interventions
DEVICE
CardioMEMS HF System
Conditions
Heart Failure
Locations
Abbott
Pleasanton, California 94588
United States