Epicardial Stimulation of the Cardiac Autonomic Nervous System

Study Overview
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Brief Summary
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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
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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.

Official Title
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EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System

Conditions
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Cardiac Insufficiency

Intervention / Treatment
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* Procedure: Electrical stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>3 cycles of electrical stimualtions will be done at the end of cardiac surgery, before end of surgery (patient closure), under anaesthesia. Cardiac outcomes will be monitored | Procedure: Electrical stimulation<br>* Electrical stimulation of the cardiac plexus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of cardiac output | Cardiac output (milliliter per minute) before and after stimulation | 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Cardiac rythm | Heart rate (beat per minute) before and after stimulation | 15 min | 
| Variation of aortic pressure | Aortic pressure (millimeter of mercury) before and after stimulation | 15 min | 
| Variation of pulmonary artery pressure | Pulmonary artery pressure (millimeter of mercury) before and after stimulation | 15 min | 
| Variation of central venous pressure | Central venous pressure (millimeter of mercury) before and after stimulation | 15 min | 
| Presence of atrial fibrillation | Atrial fibrillation related to stimulation | 15 min | 
| Adverses events | Advserse events during hospitalisation | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac plexus, Electrical stimulation