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

This study is currently recruiting participants.

Verified by Kantonsspital Luzern, May 2008

First Received: October 8, 2007 Last Updated: May 7, 2008 History of Changes

Sponsors and Collaborators:	Kantonsspital Luzern Inovise Medical
Information provided by:	Kantonsspital Luzern
ClinicalTrials.gov Identifier:	NCT00541541

Purpose

In this study, we 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:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Acoustic Cardiographic Assessment of Heart Function and the Role of Phrenic Nerve Stimulation Following Open Heart Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Kantonsspital Luzern:

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

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

Contacts

Contact: Paul Erne, MD

++41 (0)41 205 5106

Paul.Erne@KSL.CH

Locations

Switzerland
Kantonsspital Luzern, Department of Cardiology	Recruiting
Luzern, Switzerland, 6000
Contact: Paul Erne, MD ++41 (0)41 205 5106 Paul.Erne@KSL.CH

Sponsors and Collaborators

Kantonsspital Luzern

Inovise Medical

Investigators

Study Chair:

Paul Erne, MD

Kantonsspital Luzern

More Information

No publications provided

Responsible Party:	Kantonsspital Luzern ( Paul Erne )
Study ID Numbers:	Audicor-Pacing
Study First Received:	October 8, 2007
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00541541 History of Changes
Health Authority:	Switzerland: Ethikkommission

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2009