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出境医 / 临床实验 / Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. (iD-System)
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. (iD-System)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ventricular Fibrillation Ventricular Tachycardia | Procedure: Internal defibrillation during cardiac surgery, using the iD-system | Not Applicable |
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
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | N/A |
| 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. |
| Primary Purpose: | Treatment |
| 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 3, 2018 |
| Actual Primary Completion Date : | May 6, 2019 |
| Actual Study Completion Date : | July 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
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.
|
Outcome Measures
Primary Outcome Measures :
- Number of Patients With 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.
- Number of Patients With Increased Troponin-t Level Classified as Adverse Event [ 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.
- Number of Patients Where the iD-System TM Fails [ 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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| Belgium | |
| Ziekenhuis Oost-Limburg | |
| Genk, Belgium, B3600 | |
Sponsors and Collaborators
SMART Clinical Products BV
Ziekenhuis Oost-Limburg
Investigators
| Principal Investigator: | M. Beran, Dr. | Anesthesiologist |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 17, 2019 | ||||
| First Posted Date ICMJE | July 8, 2019 | ||||
| Results First Submitted Date ICMJE | October 6, 2020 | ||||
| Results First Posted Date ICMJE | February 2, 2021 | ||||
| Last Update Posted Date | February 2, 2021 | ||||
| Actual Study Start Date ICMJE | September 3, 2018 | ||||
| Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. | ||||
| Official Title ICMJE | The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System | ||||
| 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:
|
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A 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. Primary Purpose: Treatment
|
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| Condition ICMJE |
|
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| Intervention ICMJE | 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.
|
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| Study Arms ICMJE | 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.
Intervention: Procedure: Internal defibrillation during cardiac surgery, using the iD-system
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
100 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | July 31, 2019 | ||||
| Actual Primary Completion Date | May 6, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04011631 | ||||
| Other Study ID Numbers ICMJE | iD-System | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | SMART Clinical Products BV | ||||
| Study Sponsor ICMJE | SMART Clinical Products BV | ||||
| Collaborators ICMJE | Ziekenhuis Oost-Limburg | ||||
| Investigators ICMJE |
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| PRS Account | SMART Clinical Products BV | ||||
| Verification Date | January 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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