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Sponsors and Collaborators: |
Kantonsspital Luzern Inovise Medical |
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Information provided by: | Kantonsspital Luzern |
ClinicalTrials.gov Identifier: | NCT00769678 |
This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.
Condition | Intervention |
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Heart Failure |
Device: Stimulation of the diaphragm |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Crossover Assignment |
Official Title: | Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial) |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stimulation of diaphragm: Active Comparator |
Device: Stimulation of the diaphragm
Stimulation of the diaphragm using an electrode
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No stimulation of diaphragm: No Intervention |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul Erne, MD | ++41 (0)41 205 5106 | Paul.Erne@KSL.CH |
Switzerland | |
Kantonsspital Luzern | Recruiting |
Luzern, Switzerland, 6000 | |
Contact: Paul Erne, MD ++41 (0)41 205 5106 Paul.Erne@KSL.CH | |
Principal Investigator: Paul Erne, MD |
Responsible Party: | Kantonsspital Luzern ( Paul Erne ) |
Study ID Numbers: | Epiphrenic II Pilot Trial |
Study First Received: | October 3, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00769678 |
Health Authority: | Switzerland: Ethikkommission |
Biventricular Pacing |
Heart Failure Heart Diseases |
Cardiovascular Diseases |