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Completed

NCT Number: NCT05255952

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical stimulation

Procedure

Electrical stimulation of the cardiac plexus

Primary outcomes

  1. Variation of cardiac output

    Time frame: 15 min

    Cardiac output (milliliter per minute) before and after stimulation

Secondary outcomes

  1. Variation of Cardiac rythm

    Time frame: 15 min

    Heart rate (beat per minute) before and after stimulation

  2. Variation of aortic pressure

    Time frame: 15 min

    Aortic pressure (millimeter of mercury) before and after stimulation

  3. Variation of pulmonary artery pressure

    Time frame: 15 min

    Pulmonary artery pressure (millimeter of mercury) before and after stimulation

  4. Variation of central venous pressure

    Time frame: 15 min

    Central venous pressure (millimeter of mercury) before and after stimulation

  5. Presence of atrial fibrillation

    Time frame: 15 min

    Atrial fibrillation related to stimulation

  6. Adverses events

    Time frame: 10 days

    Advserse events during hospitalisation

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

EpiCANS : Epicardial Stimulation of the Cardiac Autonomic Nervous System

Acronym: EpiCANS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2022
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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