This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.
Chan Heart Rhythm Institute
Mesa, Arizona, United States
Southwest Cardiology Associates
Mesa, Arizona, United States
Cardiovascular Consultants
Phoenix, Arizona, United States
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
Time frame: 24 weeks
Optimizer-device and -procedure related complication rate
Subjects experiencing an Optimizer device- or procedure-related complication through the 24-week study period, as determined by an independent events committee.
Time frame: 24 weeks
Total CCM delivery comparing 2 and 3-lead device configurations
A comparison will be made between the Optimizer per-protocol groups in the FIX-HF-5C (3-lead) and FIX-HF-5C2 (2-lead) device configurations to show there is no difference between the amount of CCM therapy provided by the two device configurations. Total CCM delivery (effective hours delivered) will be evaluated at the end of 24 weeks following the Optimizer implantation.
Time frame: 24 weeks
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Pima Heart Physicians, PC
Tucson, Arizona, United States
Baptist Health Systems
Lexington, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Dallas VA Hospital
Dallas, Texas, United States
CHRISTUS Trinity Mother Frances
Tyler, Texas, United States
University Hospital gGmbH Bergmannsheil
Bochum, Germany