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CardioMEMS HF System Real-World Evidence Post-Approval Study
Sponsor: Abbott Medical Devices
Summary
The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.
Official title: CardioMEMS™ HF System Real-World Evidence Post-Approval Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2500
Start Date
2022-12-15
Completion Date
2028-12-31
Last Updated
2025-04-03
Healthy Volunteers
Not specified
Interventions
CardioMEMS HF System
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.
Locations (1)
Abbott Medical
Atlanta, Georgia, United States