Cardiac Insufficiency
Conditions
Keywords
cardiac plexus, Electrical stimulation
Brief summary
The objective of the EpiCANS study is to evaluate the technique of stimulation of the cardiac autonomic nervous system (SNAC) directly at the epicardial level in humans during heart surgery. Proof of concept study
Detailed description
Isolated stimulation of the parasympathetic system induces a protective effect on long-term cardiac remodeling, but at the cost of inhibiting the sympathetic system. The role of the sympathetic system is to increase cardiac output in cases of acute heart failure. Electrical stimulation of the cardiac plexus directly at the level of the heart allows simultaneous stimulation of the sympathetic and parasympathetic systems, whose complementary and not automatically antagonistic role is now recognized. Thus, direct stimulation of the plexus would optimize cardiac function in the short and long term by instantly improving cardiac output and decreasing pulmonary resistance as described in dogs by Kobayashi et al. The objective of the EpiCANS study is to evaluate this technique in humans during cardiac surgery.
Interventions
PROCEDUREElectrical stimulation
Electrical stimulation of the cardiac plexus
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective cardiac surgery for valvular or coronary surgery * Having received written and oral information about the protocol and having signed a written informed consent * Affiliated or beneficiary of a social security plan
Exclusion criteria
* Patient with an indication for cardiac surgery: * Urgent or semi-urgent * Aortic surgery * Heart transplantation * Mechanical circulatory assistance * Patients who have already undergone cardiac surgery * Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors, persons unable to express their consent, persons hospitalized for a different reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of cardiac output | 15 min | Cardiac output (milliliter per minute) before and after stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of Cardiac rythm | 15 min | Heart rate (beat per minute) before and after stimulation |
| Variation of aortic pressure | 15 min | Aortic pressure (millimeter of mercury) before and after stimulation |
| Variation of pulmonary artery pressure | 15 min | Pulmonary artery pressure (millimeter of mercury) before and after stimulation |
| Presence of atrial fibrillation | 15 min | Atrial fibrillation related to stimulation |
| Adverses events | 10 days | Advserse events during hospitalisation |
| Variation of central venous pressure | 15 min | Central venous pressure (millimeter of mercury) before and after stimulation |
Countries
France
Outcome results
None listed