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
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