This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.
The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group 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
Observed Mortality Comparison to the Predicted Probability of Mortality
The FIX-HF-5CA Study was unofficially intended to serve as the Post-Approval Study (PAS) with the intention of collecting 3 year observed mortality data and comparing that to the predicted probability of mortality derived from two validated heart failure models \[MAGGIC (Meta-Analysis Global Group in Chronic Heart Failure) and SHFM (Seattle Heart Failure Model)\]. The objective was to show that the observed prevalence of mortality was not worse than the derived predicted probability of mortality. Upon PMA and PMA Supplement approval of the device, however, FDA and the Sponsor stopped this 5CA study and a new PAS was initiated (NCT03970343). No long-term mortality data or final analysis was collected for this study.
Time frame: 2 years 6 months
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Cardiovascular Consultants
Phoenix, Arizona, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Pima Heart
Tucson, Arizona, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Cooper University Hospital
Camden, New Jersey, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
...and 7 more locations