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Epiphrenic III Pilot Trial

Not Applicable
Conditions
Heart Failure
Interventions
Device: Diaphragmatic stimulation
Registration Number
NCT01837771
Lead Sponsor
Luzerner Kantonsspital
Brief Summary

The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
25
Inclusion Criteria
  • Symptomatic heart failure (NYHA functional classes II, III or IV)
  • Reduced left ventricular ejection fraction (LVEF) <35%
  • Guideline-recommended drug therapy
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Exclusion Criteria
  • Patient refuses study participation
  • Life expectancy presumably <1 year
  • Pregnancy
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Diaphragmatic stimulationDiaphragmatic stimulationDiaphragmatic stimulation via electrode for 4 weeks
Primary Outcome Measures
NameTimeMethod
Left ventricular ejection fractionFour weeks
NYHA functional classFour weeks
Secondary Outcome Measures
NameTimeMethod
Brain natriuretic peptide (BNP)Four weeks
6-minutes walking testFour weeks

Trial Locations

Locations (1)

Luzerner Kantonsspital

🇨🇭

Luzern, Switzerland

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