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INcrease Of VAgal TonE in CHF

NCT01303718 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2015-12-15

No results posted yet for this study

Summary

The purpose of the INOVATE-HF study is to demonstrate the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with Heart Failure.

Conditions

Interventions

DEVICE

CardioFit® System

Vagal nerve stimulation with the CardioFit® system

OTHER

Standard of Care

Usual care for LV dysfunction and heart failure (no CardioFit System implant)

Sponsors & Collaborators

  • BioControl Medical

    lead INDUSTRY

Principal Investigators

  • Douglas L. Mann, MD · Washington University School of Medicine

  • Michael Gold · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • Belgium
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Serbia
  • United Kingdom

Study Locations

More Related Trials

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 NCT01303718 on ClinicalTrials.gov