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

SMART Clinical Products

Status: Completed

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Treatments: Procedure: Internal defibrillation during cardiac surgery, using the iD-system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04011631

iD-System

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Patients with cardiac surgery

Experimental group

Description:

All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.

Treatment:

Procedure: Internal defibrillation during cardiac surgery, using the iD-system