Epicardial Stimulation of the Cardiac Autonomic Nervous System (EpiCANS)
Primary Purpose
Cardiac Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Insufficiency focused on measuring cardiac plexus, Electrical stimulation
Eligibility Criteria
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
Sites / Locations
- CHU RennesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm 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
Outcomes
Primary Outcome Measures
Variation of cardiac output
Cardiac output (milliliter per minute) before and after stimulation
Secondary Outcome Measures
Variation of Cardiac rythm
Heart rate (beat per minute) before and after stimulation
Variation of aortic pressure
Aortic pressure (millimeter of mercury) before and after stimulation
Variation of pulmonary artery pressure
Pulmonary artery pressure (millimeter of mercury) before and after stimulation
Variation of central venous pressure
Central venous pressure (millimeter of mercury) before and after stimulation
Presence of atrial fibrillation
Atrial fibrillation related to stimulation
Adverses events
Advserse events during hospitalisation
Full Information
NCT ID
NCT05255952
First Posted
February 15, 2022
Last Updated
October 9, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05255952
Brief Title
Epicardial Stimulation of the Cardiac Autonomic Nervous System
Acronym
EpiCANS
Official Title
EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Insufficiency
Keywords
cardiac plexus, Electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation
Intervention Description
Electrical stimulation of the cardiac plexus
Primary Outcome Measure Information:
Title
Variation of cardiac output
Description
Cardiac output (milliliter per minute) before and after stimulation
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Variation of Cardiac rythm
Description
Heart rate (beat per minute) before and after stimulation
Time Frame
15 min
Title
Variation of aortic pressure
Description
Aortic pressure (millimeter of mercury) before and after stimulation
Time Frame
15 min
Title
Variation of pulmonary artery pressure
Description
Pulmonary artery pressure (millimeter of mercury) before and after stimulation
Time Frame
15 min
Title
Variation of central venous pressure
Description
Central venous pressure (millimeter of mercury) before and after stimulation
Time Frame
15 min
Title
Presence of atrial fibrillation
Description
Atrial fibrillation related to stimulation
Time Frame
15 min
Title
Adverses events
Description
Advserse events during hospitalisation
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure GERVAIS, Dr
Phone
299282591
Ext
+33
Email
marie-laure.gervais@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl BOU NADER, Dr
Organizational Affiliation
CHU Rennes
Official's Role
Study Director
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure GERVAIS
Phone
0299282591
Ext
+33
Email
marie-laure.gervais@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Erwan FLECHER, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Epicardial Stimulation of the Cardiac Autonomic Nervous System
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