Evaluation of the iD-SystemTM, One-Handed Disposable Internal

Status Completed

Clinical Trial Summary

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04011631
Study type	Interventional
Source	SMART Clinical Products BV
Contact
Status	Completed
Phase	N/A
Start date	September 3, 2018
Completion date	July 31, 2019

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms