Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief 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.
Detailed 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
Interventions
PROCEDUREInternal 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
Ziekenhuis Oost-Limburg
SMART Clinical Products BV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The participants / patients treated in the study are blinded for the sponsor.
Intervention model description
Prospective interventional study with medical device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Skin Symptoms | 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. |
| Number of Patients With Increased Troponin-t Level Classified as Adverse Event | 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. |
| Number of Patients Where the iD-System TM Fails | 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 | 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. |
Countries
Belgium
Participant flow
Recruitment details
A cohort of 100 successive patients undergoing major cardiac surgery from 3 September 2018 to 6 February 2019 are included.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Patients With Cardiac Surgery | — |
|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 100 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 79 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 100 |
| other Total, other adverse events | 16 / 100 |
| serious Total, serious adverse events | 6 / 100 |
Outcome results
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.
Time frame: During intra-thoracic procedure
Population: The initial connection of the iD-system was done in all (100) cases. Paddles were tested in 98 percent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients where connection was not successful | 0 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients with visible skin irritation | 0 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients wher cable length was considered not long enough | 91 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients with connection problems with the defibrillator | 0 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients where the contact surface was not sufficient | 0 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients where th paddle was too large | 0 Participants |
| Patients With Cardiac Surgery | Ease of Use of the iD-System as Assessed Via Investigator Questionnaire | number of patients with any other problems | 0 Participants |
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.
Time frame: During intra-thoracic procedure
Population: Of the 100 patients that required cardiac surgery, 11 required defibrillation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Cardiac Surgery | Number of Patients Where the iD-System TM Fails | 1 Participants |
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.
Time frame: During intra-thoracic procedure till 36 hours post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Cardiac Surgery | Number of Patients With Increased Troponin-t Level Classified as Adverse Event | 5 Participants |
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.
Time frame: During intra-thoracic procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Cardiac Surgery | Number of Patients With Skin Symptoms | 0 Participants |