Epicardial Stimulation of the Cardiac Autonomic Nervous System (EpiCANS)

November 28, 2023 updated by: Rennes University Hospital

EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients

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
Electrical stimulation of the cardiac plexus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Study Director: Karl BOU NADER, Dr, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC21_8946_04_EpiCANS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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