Epicardial Stimulation of the Cardiac Autonomic Nervous System

Not Applicable

Recruiting

• Conditions: Cardiac Insufficiency
• Interventions: Procedure: Electrical stimulation

• Registration Number: NCT05255952
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-25
• Study Start: 2022-08-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Electrical stimulation	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

Primary Outcome Measures

Name	Time	Method
Variation of cardiac output	15 min	Cardiac output (milliliter per minute) before and after stimulation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France