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INcrease Of VAgal TonE in CHF


INcrease Of VAgal TonE in CHF (INOVATE-HF) - A Randomized Study to Establish the Safety and Efficacy of CardioFit® for the Treatment of Subjects With Heart Failure and Left Ventricular Dysfunction




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.

Study Status: Recruiting


Condition Intervention Phase
Left Ventricular Dysfunction
Heart Failure
Device: CardioFit® System
Other: Standard of Care
Phase 3

Verified by BioControl Medical October, 2013

Sponsored by: BioControl Medical
Information provided by: BioControl Medical identifier: NCT01303718

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Douglas L. Mann, MD., Study Chair
Susan Petersen-Stejskal., Study Director

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