Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation
April 16, 2013 updated by: Prof. Paul Erne, Luzerner Kantonsspital
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Luzern, Switzerland, 6000
- Kantonsspital Luzern, Department of Cardiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing
Time Frame: One day
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Paul Erne, MD, Luzerner Kantonsspital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
October 8, 2007
First Submitted That Met QC Criteria
October 8, 2007
First Posted (Estimate)
October 10, 2007
Study Record Updates
Last Update Posted (Estimate)
April 17, 2013
Last Update Submitted That Met QC Criteria
April 16, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Audicor-Pacing
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.