Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011631
Other study ID # iD-System
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2018
Est. completion date July 31, 2019

Study information

Verified date January 2021
Source SMART Clinical Products BV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 31, 2019
Est. primary completion date May 6, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk

Sponsors (2)

Lead Sponsor Collaborator
SMART Clinical Products BV Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With Skin Symptoms 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. During intra-thoracic procedure
Primary Number of Patients With Increased Troponin-t Level Classified as Adverse Event 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. During intra-thoracic procedure till 36 hours post surgery
Primary Number of Patients Where the iD-System TM Fails 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. During intra-thoracic procedure
Primary Ease of Use of the iD-System as Assessed Via Investigator Questionnaire 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.
During intra-thoracic procedure
See also
  Status Clinical Trial Phase
Recruiting NCT03453645 - Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Enrolling by invitation NCT02962076 - Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia Early Phase 1
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01791543 - Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia N/A
Terminated NCT02891863 - Low Energy Therapy to Convert Ventricular Tachycardias Phase 0
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT01294267 - Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation N/A
Terminated NCT00383799 - Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT04642963 - Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia N/A
Recruiting NCT05377216 - Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation Early Phase 1
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Completed NCT04065893 - Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Recruiting NCT03631303 - Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Recruiting NCT03611465 - Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts N/A
Suspended NCT05478213 - Ventricular Tachycardia Mechanisms N/A