INOVATE-HFIncrease of Vagal Tone in Heart Failure (clinical study; BioControl Medical)
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Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF.
Initiated in April 2011, INOVATE-HF is a prospective, randomized, controlled clinical study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure (HF).
The FDA's approval to expand INOVATE-HF is a wonderful validation of the excellent clinical work completed in phase one of the study," said Ehud Cohen, Ph.
The first patient enrollment in INOVATE-HF marks an exciting milestone for BioControl Medical," said Ehud Cohen, Ph.
I believe this will change with the INOVATE-HF study of the CardioFit system," said Dr.