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

NCT ID: NCT00541541

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Heart Failure, Congestive Cardiac Pacing, Artificial Transcutaneous Electric Nerve Stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Phrenic nerve stimulation

Patients receive a phrenic nerve stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inovise Medical

INDUSTRY

Sponsor Role collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role lead

Responsible Party

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Prof. Paul Erne

Prof. Paul Erne

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Erne, MD

Role: STUDY_CHAIR

Luzerner Kantonsspital

Locations

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Kantonsspital Luzern, Department of Cardiology

Lucerne, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Audicor-Pacing

Identifier Type: -

Identifier Source: org_study_id

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