Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery
Not Applicable
Completed
- Conditions
- Heart Failure
- Interventions
- Device: Stimulation of the diaphragm
- Registration Number
- NCT00769678
- Lead Sponsor
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Patients following open heart surgery who need permanent pacing
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Exclusion Criteria
- Patients with fast changing need of vasopressors
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Stimulation of diaphragm Stimulation of the diaphragm -
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction One day
- Secondary Outcome Measures
Name Time Method 6-minutes walking distance One day Brain natriuretic peptide (BNP) One day NYHA functional class One day
Trial Locations
- Locations (1)
Kantonsspital Luzern
🇨ðŸ‡Luzern, Switzerland