CardioMEMS HF System Coverage with Evidence Development Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Abbott
RECRUITING
Pleasanton
Contact Information
Primary
Nessa Johnson
nessa.johnson@abbott.com
612-283-3865
Time Frame
Start Date: 2025-02-07
Estimated Completion Date: 2032-03
Participants
Target number of participants: 1000
Treatments
Treatment Group
Heart failure patients implanted with the CardioMEMS PA pressure sensor.
Control Group
Heart failure patients being managed without PA pressure-monitoring.
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices