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Clinical Trials/NCT01837771
NCT01837771
Unknown
Not Applicable

Uni- or Biventricular Pacing and Diaphragmatic Stimulation for Severe Heart Failure (Epiphrenic III Pilot Trial)

Luzerner Kantonsspital1 site in 1 country25 target enrollmentApril 2013
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ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Luzerner Kantonsspital
Enrollment
25
Locations
1
Primary Endpoint
Left ventricular ejection fraction
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
March 2016
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Paul Erne

Head of Department of Cardiology

Luzerner Kantonsspital

Eligibility Criteria

Inclusion Criteria

  • •Symptomatic heart failure (NYHA functional classes II, III or IV)
  • •Reduced left ventricular ejection fraction (LVEF) \<35%
  • •Guideline-recommended drug therapy

Exclusion Criteria

  • •Patient refuses study participation
  • •Life expectancy presumably \<1 year
  • •Pregnancy

Outcomes

Primary Outcomes

Left ventricular ejection fraction

Time Frame: Four weeks

NYHA functional class

Time Frame: Four weeks

Secondary Outcomes

  • Brain natriuretic peptide (BNP)(Four weeks)
  • 6-minutes walking test(Four weeks)

Study Sites (1)

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