Back to resultsAcoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
Primary Purpose
Heart Failure, Congestive, Cardiac Pacing, Artificial, Transcutaneous Electric Nerve Stimulation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Phrenic nerve stimulation
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure, Congestive
Eligibility 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
Sites / Locations
- Kantonsspital Luzern, Department of Cardiology
Outcomes
Primary Outcome Measures
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
Secondary Outcome Measures
Full Information
NCT ID
NCT00541541
First Posted
October 8, 2007
Last Updated
April 16, 2013
Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
1. Study Identification
Unique Protocol Identification Number
NCT00541541
Brief Title
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
Official Title
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Luzerner Kantonsspital
Collaborators
Inovise Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Cardiac Pacing, Artificial, Transcutaneous Electric Nerve Stimulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Phrenic nerve stimulation
Intervention Description
Patients receive a phrenic nerve stimulation
Primary Outcome Measure Information:
Title
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Erne, MD
Organizational Affiliation
Luzerner Kantonsspital
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Luzern, Department of Cardiology
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
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