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Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation

This study has been completed.
Inovise Medical
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital Identifier:
First received: October 8, 2007
Last updated: April 16, 2013
Last verified: April 2013
In this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. Heart function is assessed by acoustic cardiography.

Condition Intervention
Heart Failure, Congestive
Cardiac Pacing, Artificial
Transcutaneous Electric Nerve Stimulation
Procedure: Phrenic nerve stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery

Further study details as provided by Luzerner Kantonsspital:

Primary Outcome Measures:
  • Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing [ Time Frame: One day ]

Study Start Date: February 2007
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Phrenic nerve stimulation
    Patients receive a phrenic nerve stimulation
Detailed Description:
Patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. Heart function is postoperatively assessed by acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA) during different forms of pacing (right ventricle, left ventricle, biventricular; AAI, DDD) and with or without phrenic nerve stimulation. Acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. Effects of phrenic nerve stimulation on heart function will be analyzed.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients following open heart surgery who need temporary pacing

Exclusion Criteria:

  • Patients with permanent pacemakers
  • Patients with fast changing need of vasopressor therapy
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Please refer to this study by its identifier: NCT00541541

Kantonsspital Luzern, Department of Cardiology
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Inovise Medical
Study Chair: Paul Erne, MD Luzerner Kantonsspital
  More Information

Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital Identifier: NCT00541541     History of Changes
Other Study ID Numbers: Audicor-Pacing
Study First Received: October 8, 2007
Last Updated: April 16, 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 28, 2017