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Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

NCT03102437 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-11-23

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Daniel Burkhoff, MD, PhD · Impulse Dynamics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-12-16
Completion
2019-12-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03102437 on ClinicalTrials.gov