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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cardiac surgery | Experimental | All patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal defibrillation during cardiac surgery, using the iD-system | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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:
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. |
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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
Redo surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Beran, Dr. | Anesthesiologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | B3600 | Belgium |
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A cohort of 100 successive patients undergoing major cardiac surgery from 3 September 2018 to 6 February 2019 are included.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | During intra-thoracic procedure |
|
SAEs were reported in patients until discharge from ICU, up to 48 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment | day 2 after complex cardiac surgery: stroke due to occlusion left middle cerebral artery. Extensive infacrction with cerebral herniation. No surgical treatment. outcome: death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellie Coumans | SMART Clinical Products | +31 (0)6 53 82 70 16 | e.coumans@smartclinicalproducts.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2017 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Prospective interventional study with medical device.
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The participants / patients treated in the study are blinded for the sponsor.
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|
| During intra-thoracic procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Posted | Count of Participants | Participants | 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. | Of the 100 patients that required cardiac surgery, 11 required defibrillation. | Posted | Count of Participants | Participants | 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:
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. | The initial connection of the iD-system was done in all (100) cases. Paddles were tested in 98 percent. | Posted | Count of Participants | Participants | During intra-thoracic procedure |
|
|
|
| 3 |
| 100 |
| 6 |
| 100 |
| 16 |
| 100 |
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| Acute Kidney Injury (AKI) | Renal and urinary disorders | Systematic Assessment | Prolonged ICU length of stay with AKI, low cardiac output syndrome and ventilator-associated pneumonia. outcome: recovered |
|
| Bleeding | Vascular disorders | Systematic Assessment | D0: CABG + Mitral Valve plasty (patient known with cardiomyopathy + reduced LV function)) D1: revision for acute massive bleeding D6: revision for bleeding: vasoplegia + cardiogenic shock, resistent to therapy outcome: death Study device not used |
|
| Multi Organ Failure (MOF) | General disorders | Systematic Assessment | (D0 redo CABG + mitral valve replacement) Patient known with reduced LVEF and MI D1: Difficult weaning CPB due to LV failure and vasoplegia R/IABP In ICU deterioration of cardiogenic shock and MOF. outdome: death Study device not used |
|
| Atrial Fibbrillation | Cardiac disorders | Systematic Assessment | Atrial fibrillation, not well tolerated, loss of cardiac output resuscitation (CPR) , reintubation and ventilation reurn of spontaneous circulation within 10 minutes outcome: resolved |
|
| Status Epilepticus | Nervous system disorders | Systematic Assessment | Difficult weaning post-op CABG/AVR. EEG revealed status epilepticus (patient known with epilepsy) outcome: ongoing |
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| Multiple Organ Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Ventilator-associated pneumonia |
|
| Elevated Troponin-T level | Cardiac disorders | Systematic Assessment |
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| Low cardiac output syndrome | Cardiac disorders | Systematic Assessment | followed by ICU acquired weakness |
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| Acute Kidney Injury - Failure | Renal and urinary disorders | Systematic Assessment | known chronic renal failure |
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| Diplopia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | pituitary adenoma |
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| Trombopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Subdural hematoma | Vascular disorders | Systematic Assessment |
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| Delirum | General disorders | Systematic Assessment |
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| Decreased kidney function | Renal and urinary disorders | Systematic Assessment |
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| Endocarditis | Cardiac disorders | Systematic Assessment |
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| Ischemic stroke | Vascular disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
|
| number of patients wher cable length was considered not long enough |
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| number of patients with connection problems with the defibrillator |
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| number of patients where the contact surface was not sufficient |
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| number of patients where th paddle was too large |
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| number of patients with any other problems |
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