Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. (iD-System)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04011631|
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Fibrillation Ventricular Tachycardia||Procedure: Internal defibrillation during cardiac surgery, using the iD-system||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective interventional study with medical device.|
|Masking:||None (Open Label)|
|Masking Description:||The participants / patients treated in the study are blinded for the sponsor.|
|Official Title:||The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System|
|Actual Study Start Date :||September 1, 2018|
|Actual Primary Completion Date :||May 6, 2019|
|Estimated Study Completion Date :||July 31, 2019|
Experimental: Patients with cardiac surgery
All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation.
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.
- Safety of the iD-System as assessed by skin symptoms [ Time Frame: During intra-thoracic procedure ]Safety of the iD-system will be evaluated to assess if there are skin symptoms to the electrode by confirming if irritation is visible on the back of the patient after removal of the iD elektrode or not. For the more subjects the irritation will be visible, the worse will be the safety of the iD-elektrode.
- Safety of the iD-System as assessed by troponin measurement [ Time Frame: During intra-thoracic procedure till 36 hours post surgery ]Safety of the iD-system will be evaluated via troponine measurement to assess myocardial injury. Troponine will be measured at 4, 8, 16, 24 and 36 hours post-surgery and will be reported in ng/L. A significant increase of the troponine value during these different time points indicates myocardial injury. The investigator will evaluate every case to assess if it is an Adverse Event or not.
- Efficacy of the iD-System as assessed via investigator questionnaire [ Time Frame: During intra-thoracic procedure ]Efficacy of the the iD-System will be evaluated to assess a successful restoration of the sinus rythm by counting the number of failed attempts to defibrillate which were attributable to device malfunction. This will be captured by a questionnaire, to be completed by the investigator after the surgery. A maximum of 4 shocks can be applied. If the normal arterial hearth rhythm cannot be restored after 4 shocks with the iD-System, conversion to the conventional system occurs.
- Ease of use of the iD-System as assessed via investigator questionnaire [ Time Frame: During intra-thoracic procedure ]
Ease of use of the iD-System will be evaluated by a questionnaire, to be completed after the procedure. The following items will be assessed:
- adherence of the iD-Electrode to the patient's back
- positioning of the iD-Padde for maximal contact with the heart
- working length of the following cables: iD-Electrode,iD-Paddle and the iD-SMART Cable
The questionnaire will consist of 16 questions, each addressing a specific topic of the ease of use, to be scored by the investigator from 1 to 5.
1= very poor, 2= poor, 3= neutral, 4= sufficient, 5= excellent
The higher the total score, the better the outcome of the 'ease of use' evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011631
|Genk, Belgium, B3600|
|Principal Investigator:||M. Beran, Dr.||Anesthesiologist|