Cardiofit Vagus Nerve STIMulation for treatment of heart failure patients with PRESERVED ejection fraction (VAGOSTIM-PRESERVED)
Withdrawn
- Conditions
- 10019280Heart failure with preserved ejection fraction
- Registration Number
- NL-OMON35255
- Lead Sponsor
- BioControl Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
Inclusion Criteria
diastolic heartfailure NYHA II-IV with EF > 50%
stable patients
Nt pro bnp > 200 pg/ml
resting heart rate between 70-130
signed informed consent
Exclusion Criteria
presence of life threatening condition other than heart failure
definite or probable pulmonary disease
significant renal dysfunction
cabg, pci, acs or valve replacement in last 3 months or planned for next 12 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety endpoints: The incidence of all adverse events (system and/or procedure<br /><br>related).<br /><br>Performance endpoints: NYHA class; QoL; Exercise capacity (by 6-min walk);<br /><br>Oxygen consumption (peak VO2); Ejection fraction; Circulating cytokines, and<br /><br>N-Terminal Pro-BNP. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>