NCT05255952

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 16, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.2 years

First QC Date

February 15, 2022

Last Update Submit

September 25, 2024

Conditions

Cardiac Insufficiency

Keywords

cardiac plexusElectrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Variation of cardiac output

    Cardiac output (milliliter per minute) before and after stimulation

    15 min

Secondary Outcomes (6)

  • Variation of Cardiac rythm

    15 min

  • Variation of aortic pressure

    15 min

  • Variation of pulmonary artery pressure

    15 min

  • Variation of central venous pressure

    15 min

  • Presence of atrial fibrillation

    15 min

  • +1 more secondary outcomes

Study Arms (1)

Patients

EXPERIMENTAL

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

Interventions

Electrical stimulationPROCEDURE

Electrical stimulation of the cardiac plexus

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Karl BOU NADER, Dr

    CHU Rennes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2022

First Posted

February 25, 2022

Study Start

August 16, 2022

Primary Completion

October 13, 2023

Study Completion

November 13, 2023

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)