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NCT00541541 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

Official title:
Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00541541
Other study ID # Audicor-Pacing
Secondary ID
Status Completed
Phase N/A
First received October 8, 2007
Last updated April 16, 2013
Start date February 2007

Study information
Verified date April 2013
Source Luzerner Kantonsspital
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Phrenic nerve stimulation
Patients receive a phrenic nerve stimulation

Locations
Country Name City State
Switzerland Kantonsspital Luzern, Department of Cardiology Luzern

Sponsors (2)
Lead Sponsor Collaborator
Luzerner Kantonsspital Inovise Medical

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing One day No
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