Epicardial Stimulation of the Cardiac Autonomic Nervous System (EpiCANS)

Rennes University Hospital

Status: Completed

Conditions: Cardiac Insufficiency

Treatments: Procedure: Electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05255952

35RC21_8946_04_EpiCANS

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Patients

Experimental group

Description:

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

Treatment:

Procedure: Electrical stimulation