Carolinas HealthCare System

Research and Clinical Trials

Title  
COUNTER-HF
Brief Description  
To determine whether the use of the C-Pulse(R) System, as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse(R) System merits Food and Drug Administration (FDA) approval to market the device in the US. The C-Pulse(R) system is intended to relieve the symptoms of heart failure, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization. It is intended for use in hospital and at home
Who may be Eligible  
Patients must have a left ventricular ejection fraction (LVEF) = 35%, must be greater than 18 years of age, and must be on stable medical therapy, among other entry criteria. The study doctor(s) can provide additional information regarding study eligibility.
Start Date  
12/04/2013
IRB Number  
12-13-08A
Principal Investigator  
Frank, Theodore
Contact Name  
Connie

For More Information, Contact   Connie  Dellinger , RN
Phone:  (704) 355-4797  Fax:  (704) 355-7264 
Email:  SHVIClinicalResearch@carolinashealthcare.org
Address:  1001 Blythe Blvd., MCP M-201
Charlotte, NC 28203
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