Heart Failure
Conditions
Keywords
Biventricular Pacing
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).
Interventions
DEVICEStimulation of the diaphragm
Stimulation of the diaphragm using an electrode
Sponsors
Inovise Medical
Luzerner Kantonsspital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients following open heart surgery who need permanent pacing
Exclusion criteria
* Patients with fast changing need of vasopressors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction | One day |
Secondary
| Measure | Time frame |
|---|---|
| Brain natriuretic peptide (BNP) | One day |
| 6-minutes walking distance | One day |
| NYHA functional class | One day |
Countries
Switzerland
Outcome results
None listed