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Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

This study has been completed.
Sponsor:
Collaborator:
Inovise Medical
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00769678
First received: October 3, 2008
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.


Condition Intervention
Heart Failure
 Device: Stimulation of the diaphragm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brain natriuretic peptide (BNP) [ Time Frame: One day ] [ Designated as safety issue: No ]
  • 6-minutes walking distance [ Time Frame: One day ] [ Designated as safety issue: No ]
  • NYHA functional class [ Time Frame: One day ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2008
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stimulation of diaphragm Device: Stimulation of the diaphragm
Stimulation of the diaphragm using an electrode

Detailed Description:

Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients following open heart surgery who need permanent pacing

Exclusion Criteria:

  • Patients with fast changing need of vasopressors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769678

Locations
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Inovise Medical
  More Information

No publications provided

Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00769678     History of Changes
Other Study ID Numbers: Epiphrenic II Pilot Trial
Study First Received: October 3, 2008
Last Updated: April 16, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Luzerner Kantonsspital:
Biventricular Pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013