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