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Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5

NCT00112125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2020-08-06

Study results available
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Summary

The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

OPTIMIZER System

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • Dan Burkhoff, M.D, Ph.D. · 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
2005-02-28
Primary Completion
2019-03-19
Completion
2019-03-19

Countries

  • United States

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 NCT00112125 on ClinicalTrials.gov