Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. (iD-System)

The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System

The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Procedure: Internal defibrillation during cardiac surgery, using the iD-system

Detailed Description

The main aim is to evaluate the safety and efficacy of the iD-System™, One-handed Disposable Internal Defibrillation System The device is made for manual defibrillation during intra-thoracic procedure, by transferring a shock from a defibrillation device to the patient's heart, in combination with the iD-Electrode. The device will be used when the patient reaches a stage of ventricular fibrillation or rapid ventricular tachycardia during cardiac surgery.

In case ventricular fibrillation occurs and the iD-system is not effective to restore the sinus trythm, the conventional approach with use of the two paddels spoons will be performed immediately.

the following will be assessed:

• Ease of use of the device
• Safety of the device
• Efficacy of the device

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, B3600
    • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All races and ethnicity (>18 years)
• Written informed consent form (ICF) has to be obtained from the patient.

• Elective surgery: cardiac surgery on pump (CPB)

  • Coronary artery bypass surgery

  • Heart valve repair and/or replacement

    • Mini sternotomy
    • Median sternotomy
  • Redo surgery

Exclusion Criteria:

• Patients without cardiopulmonary bypass (referred to as heart-lung machine or pump)
• Emergency surgery without a sufficient amount of time to explain and ask for ICF

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with cardiac surgery; All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.	Procedure: Internal defibrillation during cardiac surgery, using the iD-system; When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Skin Symptoms	Safety of the iD-system will be evaluated to assess if there are skin symptoms to the electrode by confirming if irritation is visible on the back of the patient after removal of the iD elektrode or not. For the more subjects the irritation will be visible, the worse will be the safety of the iD-elektrode.	During intra-thoracic procedure
Number of Patients With Increased Troponin-t Level Classified as Adverse Event	Safety of the iD-system will be evaluated via troponine measurement to assess myocardial injury. Troponine will be measured at 4, 8, 16, 24 and 36 hours post-surgery and will be reported in ng/L. A significant increase of the troponine value during these different time points indicates myocardial injury. The investigator will evaluate every case to assess if it is an Adverse Event or not.	During intra-thoracic procedure till 36 hours post surgery
Number of Patients Where the iD-System TM Fails	Efficacy of the the iD-System will be evaluated to assess a successful restoration of the sinus rythm by counting the number of failed attempts to defibrillate which were attributable to device malfunction. This will be captured by a questionnaire, to be completed by the investigator after the surgery. A maximum of 4 shocks can be applied. If the normal arterial hearth rhythm cannot be restored after 4 shocks with the iD-System, conversion to the conventional system occurs.	During intra-thoracic procedure
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire	Ease of use of the iD-System will be evaluated by a questionnaire, to be completed after the procedure. The following items will be assessed: adherence of the iD-Electrode to the patient's back; positioning of the iD-Padde for maximal contact with the heart; working length of the following cables: iD-Electrode,iD-Paddle and the iD-SMART Cable The questionnaire will consist of 16 questions, each addressing a specific topic of the ease of use, to be scored by the investigator from 1 to 5. 1= very poor, 2= poor, 3= neutral, 4= sufficient, 5= excellent The higher the total score, the better the outcome of the 'ease of use' evaluation.	During intra-thoracic procedure

Collaborators and Investigators

• Sponsor: SMART Clinical Products BV
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: M. Beran, Dr., Anesthesiologist

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): May 6, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (ACTUAL): July 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: iD-System

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