CardioMEMS HF System Coverage With Evidence Development Study
Recruiting · NCT06779552 · Observational (researchers observe without assigning treatment) · Lead sponsor: Abbott Medical Devices
View the official record on ClinicalTrials.gov →Interventions studied
CardioMEMS HF System
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed across 1 US state.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →