Clinical trial NCT04011631: Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
Official title: The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Lead sponsor: SMART Clinical Products BV
Sponsor class: INDUSTRY
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2019-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective interventional study with medical device.
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Skin Symptoms
timeFrame: During intra-thoracic procedure
measure: Number of Patients With Increased Troponin-t Level Classified as Adverse Event
timeFrame: During intra-thoracic procedure till 36 hours post surgery
measure: Number of Patients Where the iD-System TM Fails
timeFrame: During intra-thoracic procedure
measure: Ease of Use of the iD-System as Assessed Via Investigator Questionnaire
timeFrame: During intra-thoracic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Anesthesiologist
name: M. Beran, Dr.
role: PRINCIPAL_INVESTIGATOR
References: