Epicardial Stimulation of the Cardiac Autonomic Nervous System

Cardiac Insufficiency Clinical Trial

— EpiCANS  

Official title:

EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255952
• Other study ID #: 35RC21_8946_04_EpiCANS
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Rennes University Hospital
• Contact: Marie-Laure GERVAIS, Dr
• Phone: 299282591
• Email: marie-laure.gervais[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Insufficiency
• Heart Failure

Intervention

Procedure:
• Electrical stimulation
Electrical stimulation of the cardiac plexus

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of cardiac output	Cardiac output (milliliter per minute) before and after stimulation	15 min
Secondary	Variation of Cardiac rythm	Heart rate (beat per minute) before and after stimulation	15 min
Secondary	Variation of aortic pressure	Aortic pressure (millimeter of mercury) before and after stimulation	15 min
Secondary	Variation of pulmonary artery pressure	Pulmonary artery pressure (millimeter of mercury) before and after stimulation	15 min
Secondary	Variation of central venous pressure	Central venous pressure (millimeter of mercury) before and after stimulation	15 min
Secondary	Presence of atrial fibrillation	Atrial fibrillation related to stimulation	15 min
Secondary	Adverses events	Advserse events during hospitalisation	10 days