Study:
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
Rationale:
n/a
Purpose:
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
Recruiting:
| Condition |
Intervention |
Phase |
Left Ventricular Dysfunction Heart Failure |
Device: CardioFit® System Other: Standard of Care |
Phase 3 |
Verified by
BioControl Medical
May, 2013
Sponsored by: BioControl Medical
Information provided by: BioControl Medical
ClinicalTrials.gov 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