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Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System — FIX-HF-5CA  

Heart Failure Clinical Trial

Official title:
FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%

Clinical Trial Summary

This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03102437
Study type Interventional
Source Impulse Dynamics
Contact
Status Terminated
Phase N/A
Start date July 1, 2017
Completion date December 16, 2019
View Details
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