NCT01303718

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 730 (actual)
• Sponsor: BioControl Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, Randomized (3:2 active:control), Open Label, Event-driven Interventional Study. All subjects undergo the following: Baseline, Randomization, (Implantation \& Optimization for subjects randomized to the active therapy), and Follow-up Period, followed by an Extension period, which lasts until the end of the study. The Clinical Events Committee (CEC) and Data Monitoring and Safety Board (DSMB) will conduct scheduled independent reviews of the data at the following time-points in order to ensure that an ongoing acceptable safety profile is being achieved.

Conditions

• Left Ventricular Dysfunction
• Heart Failure

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-02-25
• Last updated: 2015-12-15

Locations

87 sites across 8 countries: United States, Belgium, Germany, Israel, Netherlands, Poland, Serbia, United Kingdom