NCT04011631View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL

Enrollment

100

Participants

Timeline

Start Date

September 3, 2018

Primary Completion Date

May 6, 2019

Study Completion Date

July 31, 2019

Conditions

Ventricular FibrillationVentricular Tachycardia

Interventions

PROCEDURE

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.

Trial Locations (1)

B3600

Ziekenhuis Oost-Limburg, Genk

All Listed Sponsors

collaborator

Ziekenhuis Oost-Limburg

OTHER

lead

SMART Clinical Products BV

INDUSTRY

NCT04011631 - Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. | Biotech Hunter | Biotech Hunter