Clinical Trials Information

Please call the Impulse Dynamics toll free number 866-544-9618 to find out if you might qualify for participation.

Background on Phase II Clinical Trial of Optimizer III Implantable Pulse Generator (FIX-HF-5)
FIX-HF-5 (Fix Heart Failure 5) is a clinical study designed to investigate the safety and effectiveness of a new system called the Optimizer™ for treating heart failure patients. FIX-HF-5 is targeting to enroll approximately 420 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites.

About The Optimizer™ System
The Optimizer System is designed for the treatment of patients with moderate to severe heart failure. Optimizer technology is based on a new method known as Cardiac Contractility Modulation (CCM). CCM is a method for treating failing hearts in which non-excitatory impulses are delivered to the heart during a period of time called the absolute refractory period (ARP). Therefore, these signals do not initiate the heart to beat (like a pacemaker would). Rather, these signals are intended to modify heart cell function for the treatment of heart failure.

Eligible Patients
Each patient enrolled in the FIX-HF-5 must meet the following specific entry criteria:

• be older than 18 years
• have received standard heart failure therapy for at least 90 days including use of stable doses of diuretic, ACE-I and beta-blocker for 30 days
• be able to complete exercise tolerance tests  
• have an ejection fraction less than or equal to 35%
• be willing to return for follow ups
• be able to provide informed consent

Patients eligible for FIX-HF-5 may undergo simultaneous implant of a pacemaker or an ICD at the time of the implant of the Optimizer™ System or may already have such devices.

Non-Eligible Patients
Patients not eligible for the FIX-HF-5 clinical trial include those who have: correctable cause of heart failure, chronic atrial fibrillation, clinically significant angina pectoris or experienced a heart attack within the past 3 months. Patients currently receiving biventricular (BiV) pacing, who are indicated for BiV or whose exercise tolerance is limited by non-heart failure conditions are also excluded from this study.