Ventricular FibrillationiD-SystemNCT04011631
Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System.
A study testing Internal defibrillation during cardiac surgery, using the iD-system in people with Ventricular Fibrillation and Ventricular Tachycardia, run by SMART Clinical Products BV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Fibrillation, Ventricular Tachycardia
- What is being tested?
- Internal defibrillation during cardiac surgery, using the iD-system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Sep 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
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.
Read the 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
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia
- Being tested
- Internal defibrillation during cardiac surgery, using the iD-system
- Medical subject headings
- Ventricular Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal defibrillation during cardiac surgery, using the iD-systemProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Internal defibrillation during cardiac surgery, using the iD-system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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:
- 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.
Measured: During intra-thoracic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start3 Sep 2018
- Primary completion6 May 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective interventional study with medical device.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMART Clinical Products BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Sponsor
- Investigators
- M. Beran, Dr., Principal investigator, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011631
- Sponsor's protocol ID
- iD-System
- Acronym
- iD-System
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2019
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
- ClinicalTrials.gov ID
- NCT04011631
- Acronym / sponsor ID
- iD-System / iD-System
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- SMART Clinical Products BVIndustry (pharma, biotech, devices)
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective interventional study with medical device.
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiac surgery | Experimental | Procedure: Internal defibrillation during cardiac surgery, using the iD-systemAll patients undergoing cardiac surgery at the Ziekenhuis Oost-Limburg, meeting all inclusion and no exclusion criteria, are asked to participate in the investigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal defibrillation during cardiac surgery, using the iD-systemWhen 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. | Procedure or surgery | Patients with cardiac surgery |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Beran, Dr. principal investigator
Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal defibrillation during cardiac surgery, using the iD-system in people with Ventricular Fibrillation and Ventricular Tachycardia, run by SMART Clinical Products BV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Skin Symptoms (time frame: During intra-thoracic procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.