CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Internal defibrillation during cardiac surgery, using the iD-systemprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04011631
NCT04011631N/ACompleted
CompareCT.gov

The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System

SMART Clinical Products BV·interventional·Posted Jul 8, 2019·Updated Feb 2, 2021

In Brief

A clinical study evaluating Internal defibrillation during cardiac surgery, using the iD-system for Ventricular Fibrillation and Ventricular Tachycardia. Completed, enrolled 100 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Fibrillation, Ventricular Tachycardia
CountriesBelgium
CollaboratorsZiekenhuis Oost-Limburg

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 8, 2019
Enrollment StartSep 3, 2018
Primary CompletionMay 6, 2019
Study CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.0 years ago

Interventions

Internal defibrillation during cardiac surgery, using the iD-systemprocedure

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.