Trial Outcomes & Findings for Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. (NCT NCT04011631)

Last Updated: 2021-02-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

During intra-thoracic procedure

Results posted on

2021-02-02

Participant Flow

A cohort of 100 successive patients undergoing major cardiac surgery from 3 September 2018 to 6 February 2019 are included.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Cardiac Surgery n=100 Participants 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.
Age, Continuous	67 years STANDARD_DEVIATION 10 • n=100 Participants
Sex: Female, Male Female	21 Participants n=100 Participants
Sex: Female, Male Male	79 Participants n=100 Participants
Region of Enrollment Belgium	100 Participants n=100 Participants

PRIMARY outcome

Timeframe: During intra-thoracic procedure

Outcome measures

Outcome measures
Measure	Patients With Cardiac Surgery n=100 Participants 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.
Number of Patients With Skin Symptoms	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Cardiac Surgery n=100 Participants 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.
Number of Patients With Increased Troponin-t Level Classified as Adverse Event	5 Participants

PRIMARY outcome

Timeframe: During intra-thoracic procedure

Population: Of the 100 patients that required cardiac surgery, 11 required defibrillation.

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.

Outcome measures

Outcome measures
Measure	Patients With Cardiac Surgery n=11 Participants 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.
Number of Patients Where the iD-System TM Fails	1 Participants

PRIMARY outcome

Timeframe: During intra-thoracic procedure

Population: The initial connection of the iD-system was done in all (100) cases. Paddles were tested in 98 percent.

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.

Outcome measures

Outcome measures
Measure	Patients With Cardiac Surgery n=100 Participants 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.
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients where connection was not successful	0 Participants
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients with visible skin irritation	0 Participants
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
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients with connection problems with the defibrillator	0 Participants
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients where the contact surface was not sufficient	0 Participants
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients where th paddle was too large	0 Participants
Ease of Use of the iD-System as Assessed Via Investigator Questionnaire number of patients with any other problems	0 Participants

Adverse Events

Patients With Cardiac Surgery

Serious events: 6 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Cardiac Surgery n=100 participants at risk 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.
Vascular disorders Stroke	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Renal and urinary disorders Acute Kidney Injury (AKI)	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Vascular disorders Bleeding	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
General disorders Multi Organ Failure (MOF)	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Cardiac disorders Atrial Fibbrillation	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Nervous system disorders Status Epilepticus	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.

Other adverse events

Other adverse events
Measure	Patients With Cardiac Surgery n=100 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.0% 4/100 • Number of events 4 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Respiratory, thoracic and mediastinal disorders Multiple Organ Failure	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Cardiac disorders Elevated Troponin-T level	5.0% 5/100 • Number of events 5 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Cardiac disorders Low cardiac output syndrome	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Renal and urinary disorders Acute Kidney Injury - Failure	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diplopia	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Blood and lymphatic system disorders Trombopenia	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Vascular disorders Subdural hematoma	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
General disorders Delirum	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Renal and urinary disorders Decreased kidney function	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Cardiac disorders Endocarditis	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Vascular disorders Ischemic stroke	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 1/100 • Number of events 1 • SAEs were reported in patients until discharge from ICU, up to 48 hours.

Additional Information

Ellie Coumans

SMART Clinical Products

Phone: +31 (0)6 53 82 70 16

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place