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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00769678
First Posted: October 9, 2008
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Inovise Medical
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital
  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: None (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:


Further study details as provided by Prof. Paul Erne, Luzerner Kantonsspital:

Primary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: One day ]

Secondary Outcome Measures:
  • Brain natriuretic peptide (BNP) [ Time Frame: One day ]
  • 6-minutes walking distance [ Time Frame: One day ]
  • NYHA functional class [ Time Frame: One day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769678


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00769678     History of Changes
Other Study ID Numbers: Epiphrenic II Pilot Trial
First Submitted: October 3, 2008
First Posted: October 9, 2008
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Prof. Paul Erne, Luzerner Kantonsspital:
Biventricular Pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases