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

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ClinicalTrials.gov Identifier: NCT00769678
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : April 17, 2013
Sponsor:
Collaborator:
Inovise Medical
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital

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

Condition or disease Intervention/treatment Phase
Heart Failure Device: Stimulation of the diaphragm Not Applicable

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)
Study Start Date : October 2008
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Stimulation of diaphragm Device: Stimulation of the diaphragm
Stimulation of the diaphragm using an electrode



Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: One day ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients following open heart surgery who need permanent pacing

Exclusion Criteria:

  • Patients with fast changing need of vasopressors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769678


Locations
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6000
Sponsors and Collaborators
Luzerner Kantonsspital
Inovise Medical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT00769678     History of Changes
Other Study ID Numbers: Epiphrenic II Pilot Trial
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Keywords provided by Prof. Paul Erne, Luzerner Kantonsspital:
Biventricular Pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases