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

This study has been completed.
Sponsor:
Collaborator:
Inovise Medical
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT00541541
First received: October 8, 2007
Last updated: April 16, 2013
Last verified: April 2013
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

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 temporary pacing

Exclusion Criteria:

  • Patients with permanent pacemakers
  • Patients with fast changing need of vasopressor therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014