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.
Completed
- Conditions
- Heart failure10019280
- Registration Number
- NL-OMON41238
- Lead Sponsor
- BioControl Medical (B.C.M.) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method