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

NCT04011631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-02

Study results available
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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.

Conditions

  • Ventricular Fibrillation
  • Ventricular 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.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • SMART Clinical Products BV

    lead INDUSTRY

Principal Investigators

  • M. Beran, Dr. · Anesthesiologist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2019-05-06
Completion
2019-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011631 on ClinicalTrials.gov