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Completed

NCT Number: NCT04011631

Evaluation of the iD-SystemTM, 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.

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Key information

Conditions

Ventricular Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, B3600, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Internal defibrillation during cardiac surgery, using the iD-system

Procedure

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.

Primary outcomes

  1. Number of Patients With Skin Symptoms

    Time frame: During intra-thoracic procedure

    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.

  2. Number of Patients With Increased Troponin-t Level Classified as Adverse Event

    Time frame: During intra-thoracic procedure till 36 hours post surgery

    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.

  3. Number of Patients Where the iD-System TM Fails

    Time frame: During intra-thoracic procedure

    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.

  4. Ease of Use of the iD-System as Assessed Via Investigator Questionnaire

    Time frame: During intra-thoracic procedure

    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.

Sponsors and collaborators

Lead sponsor

SMART Clinical Products BV

Industry

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: iD-System

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Feb 2, 2021

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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