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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-07-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Ventricular Fibrillation Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective interventional study with medical device.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The participants / patients treated in the study are blinded for the sponsor.

Study Groups

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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.

Group Type EXPERIMENTAL

Internal defibrillation during cardiac surgery, using the iD-system

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No