Skip to main content
Clinical Trials/NL-OMON41238
NL-OMON41238
Completed
Not Applicable

INcrease Of VAgal TonE in chronic Heart Failure (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. A pivotal trial to establish the long-term safety and efficacy of the cardiofit system. - CardioFit Pivotal Study for the treatment of Heart Failure. INOVATE-HF

BioControl Medical (B.C.M.) Ltd.0 sites30 target enrollmentStarted: TBDLast updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
BioControl Medical (B.C.M.) Ltd.
Enrollment
30

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • Subjects with LV systolic dysfunction (EF\<40%) and heart failure in NYHA functional class III, who are on, and have failed to achieve symptom relief despite standerd evidence\-based management per applicable guidelines.

Exclusion Criteria

  • Presence of a life threatening condition or disease other than heart failure, such as cancer, terminal renal failure or a progressive neurological disorder, that is likely to lead to death within 180 days.

Investigators

Sponsor
BioControl Medical (B.C.M.) Ltd.

Similar Trials