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Completed

NCT Number: NCT00541541

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Luzern, Department of Cardiology

Lucerne, Canton of Lucerne, 6000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phrenic nerve stimulation

Procedure

Patients receive a phrenic nerve stimulation

Primary outcomes

  1. Change of electrical mechanical activation time (EMAT) as measure of heart function on different settings of pacing

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • Inovise Medical

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
First posted
Oct 10, 2007
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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