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Cardiofit Vagus Nerve STIMulation for treatment of heart failure patients with PRESERVED ejection fraction (VAGOSTIM-PRESERVED)

Cardiofit Vagus Nerve STIMulation for treatment of heart failure patients with PRESERVED ejection fraction (VAGOSTIM-PRESERVED) - VAGOSTIM-PRESERVED

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35255
Enrollment
4
Registered
2010-06-11
Start date
2009-12-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction

Interventions

System implantation, device activation in a stepwise fashion to achieve optimal stimulation. Treatment and observation.

Sponsors

BioControl Medical
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Safety endpoints: The incidence of all adverse events (system and/or procedure related). Performance endpoints: NYHA class; QoL; Exercise capacity (by 6-min walk); Oxygen consumption (peak VO2); Ejection fraction; Circulating cytokines, and N-Terminal Pro-BNP.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)