NCT03102437

Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

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%

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Impulse Dynamics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Heart Failure
• Congestive Heart Failure
• Chronic Heart Disease
• CHF

Interventions

Type	Name	Description
DEVICE	Optimizer Smart System	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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-12-16
• Completion: 2019-12-16
• First posted: 2017-04-05
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study