iD-SystemThe Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
Internal defibrillation during cardiac surgery, using the iD-system
Cardiac Conduction System Disease+6
+ Arrhythmias, Cardiac
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: September 3, 2018
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location