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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014