Stopped: Enrollment for this study was stopped following approval of the C-Pulse System pivotal study IDE.This decision was not based on any safety concerns.
The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percent of Patients with a Device-Related Adverse Event
Timeframe: Through 6 months
Quality of Life (QOL)
Timeframe: 6 months
New York Heart Association (NYHA) Classification
Timeframe: 6 months
Improvement in 6 Minute Walk Test (6MWT)
Timeframe: 6 months