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Completed

NCT Number: NCT00769678

Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

About this study

Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

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 permanent pacing

Exclusion criteria

  • Patients with fast changing need of vasopressors

Treatment and study plan

Stimulation of the diaphragm

Device

Stimulation of the diaphragm using an electrode

Primary outcomes

  1. Left ventricular ejection fraction

    Time frame: One day

Secondary outcomes

  1. Brain natriuretic peptide (BNP)

    Time frame: One day

  2. 6-minutes walking distance

    Time frame: One day

  3. NYHA functional class

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Luzerner Kantonsspital

Other

Collaborators

  • Inovise Medical

Registry information

Official study title

Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)

Important dates

Study start
2008
Primary completion
2012
First posted
Oct 9, 2008
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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