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Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C

NCT01381172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-09-17

Study results available
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Summary

The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.

Conditions

  • NYHA Class III Heart Failure
  • NYHA Class IV Heart Failure

Interventions

DEVICE

Optimizer System

The OPTIMIZER 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.

OTHER

No intervention: Optimal medical therapy

The control group receives optimal medical therapy only.

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Daniel Burkhoff, MD, PhD · Impulse Dynamics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2019-03-19
Completion
2019-03-19

Countries

  • United States
  • Czechia
  • Germany

Study Locations

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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 NCT01381172 on ClinicalTrials.gov