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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00541541
First Posted: October 10, 2007
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
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: None (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 Prof. Paul Erne, 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.
  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 temporary pacing

Exclusion Criteria:

  • Patients with permanent pacemakers
  • Patients with fast changing need of vasopressor therapy
  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): NCT00541541


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

Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00541541     History of Changes
Other Study ID Numbers: Audicor-Pacing
First Submitted: October 8, 2007
First Posted: October 10, 2007
Last Update Posted: April 17, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases