Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery - Full Text View

Sponsors and Collaborators:	Kantonsspital Luzern Inovise Medical
Information provided by:	Kantonsspital Luzern
ClinicalTrials.gov Identifier:	NCT00769678

Purpose

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
Heart Failure	Device: Stimulation of the diaphragm

MedlinePlus related topics: Heart Failure Heart Surgery

U.S. FDA Resources

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)

Further study details as provided by Kantonsspital Luzern:

Primary Outcome Measures:

Electrical mechanical activation time (EMAT) [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Brain natriuretic peptide (BNP) [ Time Frame: One day ] [ Designated as safety issue: No ]
6-minutes walking distance [ Time Frame: One day ] [ Designated as safety issue: No ]
Left ventricular ejection fraction [ Time Frame: One day ] [ Designated as safety issue: No ]

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
Stimulation of diaphragm: Active Comparator	Device: Stimulation of the diaphragm Stimulation of the diaphragm using an electrode
No stimulation of diaphragm: No Intervention

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769678

Contacts

Contact: Paul Erne, MD

++41 (0)41 205 5106

Paul.Erne@KSL.CH

Locations

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

Sponsors and Collaborators

Kantonsspital Luzern

Inovise Medical

More Information

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

Keywords provided by Kantonsspital Luzern:

Biventricular Pacing

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009