Biventricular Pacing and Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery (Epiphrenic II Pilot Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Luzerner Kantonsspital
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Left ventricular ejection fraction
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
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).
Investigators
Prof. Paul Erne
Prof. Paul Erne
Luzerner Kantonsspital
Eligibility Criteria
Inclusion Criteria
- •Patients following open heart surgery who need permanent pacing
Exclusion Criteria
- •Patients with fast changing need of vasopressors
Outcomes
Primary Outcomes
Left ventricular ejection fraction
Time Frame: One day
Secondary Outcomes
- Brain natriuretic peptide (BNP)(One day)
- 6-minutes walking distance(One day)
- NYHA functional class(One day)