The Efficacy and Safety of Internal Defibrillation: Evaluation of the iD-System™, One-Handed Disposable Internal Defibrillation System
Phase: NA
Conditions: Ventricular Fibrillation, Ventricular Tachycardia
Sponsor: SMART Clinical Products BV

 
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The efficacy and safety of internal defibrillation: 
evaluation of the iD-SystemTM, One-Handed 
Disposable Internal Defibrillation System 
 
Protocol Version 1.0, 28 November 2017 
 
NCT04011631 
 
 
 
 
 
 
 
 
 
 

 
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SUMMARY 
Title 
The efficacy and safety of internal defibrillation: evaluation of the iD-
System™, One-Handed Disposable Internal Defibrillation System 
Acronym 
Internal defibrillation: iD-System™ 
Principal Investigator 
Dr. Maud Beran 
Version & date 
Version 1.0, 28 November 2017 
Company 
SMART Clinical Products 
Study site 
Ziekenhuis Oost-Limburg 
Study period 
February 2018-April 2018 
Rationale 
The iD-System™ is designed for internal defibrillation in the same manner 
as the conventional internal paddles, which are used during intra-thoracic 
surgery. It delivers a shock to a patient’s heart to restore normal sinus 
rhythm. The iD-System is a one-handed disposable medical device  
reducing the risk of cross contamination and the cost of sterilization. 
Moreover, it can be used in small-incision surgery due to its small size 
making it attractive for use in cardiac surgery. 
Objectives
The main aim is to evaluate the safety and efficacy of the iD-System
Safety: 
- 
To assess the ease of use of the device 
- 
To assess possible complications 
Efficacy: 
- 
To assess a successful restoration of the sinus rhythm 
Investigational 
material and 
comparator products 
The iD-System™ consist of two components: 
1. The iD-Paddle™ is a disposable sterile one-handed paddle. The iD-
Paddle is placed in contact with the heart when needed to deliver 
a shock to restore normal sinus rhythm. 
2. The iD-Electrode™ is a disposable non-sterile electrode pad placed 
on the back of the patient and connected to the same defibrillator 
as the iD-Paddle.  
Both the iD-Paddle™ and the iD-Electrode™ are connected with the 
defibrillator/monitor via the iD-SMART Cable. The iD-SMART Cable 
ensures that the Internal Joules Protocol will be initiated, with a 
maximum of 50 Joules. The iD-SMART Cable is specific for each type of 
defibrillator/monitor. 
Number of subjects 
planned 
100 patients with cardiac surgery, approximately 10% with need of 
internal defibrillation 
Duration of study  
3 months 

 
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Inclusion and 
exclusion 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) 
o Coronary artery bypass surgery 
o Heart valve repair and/or replacement 
 
Mini sternotomy 
 
Median sternotomy 
o 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 
 
Study design 
Prospective interventional study with medical device 
 
 
 

 
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1. ETHICS 
 
1.1. 
Independent Ethics Committee 
The protocol and local Informed Consent Form must be reviewed and approved by the institution’s 
Independent Ethics Committee (IEC) prior to the initiation of patient enrolment. The IEC will be notified 
of all subsequent protocol amendments. In addition, progress reports will be submitted to the IEC by 
the investigator as indicated by IEC’s guidelines. 
 
1.2. 
Ethical conduct of the study 
The study will be conducted in accordance with the protocol, the principles that have their origins in 
the Declaration of Helsinki, as well as ICH GCP (Version 4, June 1996) and applicable national and local 
regulatory requirements, including but not limited to the Belgian Laws of 7 May 2004 relating to 
experiments on the human person (LEH), of 22 August 2002 on Patients’ Rights and of 8 December 
1992 (as amended) regarding the Protection of Privacy in relation to the Processing of Personal Data. 
All essential documents will be archived. 
 
1.3. 
 Patient information and informed consent 
The informed consent will contain all elements required by ICH GCP. Written informed consent will be 
obtained from the patient prior to enrolment and participation of the study subject. The study centre 
further commits to conduct the study only on the basis of prior written consent by the subjects.  
 
 

 
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2. INVESTIGATORS AND STUDY ADMINISTRATION STRUCTURE 
2.1. 
Investigators 
Ziekenhuis Oost-Limburg will enroll approximately 100 patients. The trial will be supported by SMART 
Clinical Products by providing an internal defibrillation device and materials as specified above. SMART 
Clinical Products will be responsible for the technical support during the entire study period. 
 
2.2. 
Steering committee 
The Steering Committee will be responsible for the overall design, conduct, and supervision of the trial, 
including the development of the protocol and any protocol amendments. The Steering Committee 
meets periodically to assess the progress of the study to ensure subject safety and study integrity. The 
Steering Committee is composed of designated academic leaders and clinical experts. 
 
Principal Investigator  
Dr. Maud Beran (MD) 
 
Co-investigators  
Dr. Matteo Pettinari (MD) 
Dr. Herbert Gutermann (MD) 
Dr. Dieter Mesotten (MD PhD) 
 
3. INTRODUCTION 
 
In the majority of cardiac surgical interventions, cardiopulmonary bypass (CPB) is used because of the 
difficulty of operating on the beating heart. CPB is referred to as a heart- lung machine as the technique 
temporarily takes over the function of the heart (pump blood) and lungs (supply oxygen to red blood 
cells) during surgery (1).  However, it is common for the post ischemic heart to fibrillate immediately 
after reperfusion and prior to weaning from extracorporeal circulation.  This is referred to as 
ventricular fibrillation or tachycardia where cardiac electric shocks are often needed to restore the 
sinus rhythm of the heart (figure 1) (2,3). Therefore, intraoperative cardiac defibrillation is needed of 
which the most popular system consists of two spoon electrodes applied directly to the epicardium. 
The paddle handles are held by a surgeon when the electric current is passed from one spoon electrode 
through the patient's heart to a second spoon electrode (4). With the current tendency to reduce 
incision length in cardiac surgery, these paddles often turn out too bulky (5). Additionally,  prior to use, 
the defibrillation handles and electrodes must be sterilized properly to eliminate patient infection. The 
handles have to be replaced after 25 cycles using steam sterilization or 100 cycles using hydrogen 

 
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peroxide gas sterilization (6). Independent of the sterilization, a defibrillation test has to be performed 
using a defibrillator analyzer after ten sterilization cycles or quarterly whichever comes first. The 
internal electrodes have to be replaced after 10 cycles using steam and 1 cycle using gas sterilization.  
 
Figure 1: Normal and pathological electrocardiograms (ECG) related to internal fibrillation during cardiac surgery 
Recently, with this knowledge, studies have shown that systems using a single paddle and an external 
adhesive pad positioned at the patient’s back reached the same reliability and function (5).  
SMART Clinical Products developed a disposable device (iD-System™, One-handed Disposable Internal 
Defibrillation System; figure 2) consisting of a single paddle (iD-Paddle) designed with a flexible head 
to maximize the contact with the heart. The adhesive pad (iD-Electrode), positioned at the patient’s 
back, serves as a positive pole to guarantee an electric circuit transferred from a defibrillation device 
to the patient’s heart.  The iD-Sytem™ is connected to the defibrillator/monitor, via a specific iD-
SMART Cable. More information about the product, the company and their strategy is provided in the 
evaluation plan (attachment 1) and the brochure (attachment 2). 
 
Figure 2: the iD-SystemTM developed by SMART Clinical Products consisting of the iD-Paddle, the iD-Electrode and 
the iD-SMART Cable.  
In UZLeuven, this device was tested and the following conclusions were made in comparison to the 
conventional system (5) 
- 
it can easily be used as a hybrid (both external and internal cardioversion) system 
- 
it consists of disposable materials (reducing the risk of cross contamination and the cost of 
sterilization process). The iD-SMART Cable is a reusable product. The iD-SMART Cable will not 
be in direct contact with the patients tissue. 
Sinus rhythm 
Ventricular tachycardia 
Ventricular fibrillation 

 
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- 
its small size and single contact point approach permits safe use in limited access conditions 
such as with small-incision surgery and in redo surgery associated with extensive adhesions. 
 
Since it is the current that defibrillates, impedance or resistance is important. With constant energy 
selected on the defibrillator device, defibrillation effectiveness is related to the resistance between 
the defibrillator and the patient's heart (7). The lower the resistance or impedance, the higher 
the defibrillation success. Myocardial injury associated with defibrillation corresponds not only with 
total joules used (energy), but also with the time interval between the defibrillation shocks. Therefore, 
throughout the cardiac surgery, perioperative myocardial damage is measured by electrocardiogram 
(ECG) and by cardiac troponin levels. Troponin levels indicate the severity of cardiac damage(8). 
4. OBJECTIVES 
 
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.  
- 
Safety:  
o To assess the ease of use of the device:  
 
Adherence of the iD-Electrode to the patient’s back 
 
Positioning of the iD-Paddle for maximal contact with the heart 
 
Working length of the following cables: iD-Electrode, iD-Paddle and the iD-
SMART Cable 
 
Applicability in small-incision surgery: mini sternotomy 
o To assess possible complications: 
 
Skin symptoms to the electrode 
 
Myocardial injury: troponin measurement 
 
- 
Efficacy 
o To assess a successful restoration of the sinus rhythm 
 
Number of failed attempts to defibrillate which were attributable to device 
malfunction. 
 
 
 

 
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5. INVESTIGATIONAL PLAN 
5.1. 
Patient population 
 
All patients undergoing cardiac surgery, meeting all inclusion and no exclusion criteria, are asked to 
participate.  
5.2.1. 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) 
o Coronary artery bypass surgery 
o Heart valve repair and/or replacement 
 
Mini sternotomy 
 
Median sternotomy 
o Redo surgery 
5.2.2. Exclusion criteria 
- 
Patients <18 years 
- 
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 
 
 
 
5.2. 
Study design 
 
The iD-System™, One-handed Disposable Internal Defibrillation System is already tested by the 
biotechnical department of Ziekenhuis Oost Limburg (ZOL) which ensured proper working between 
the iD-System and the used defibrillator/monitor in ZOL (LIFEPAK® 20 ) (attachment 3 and attachment 
3.1). In every included patient undergoing cardiac surgery on CPB/pump (during February 1st 2018 until 
April 30rd 2018), the iD-Electrode is placed prophylactically on the patient’s back and is connected to 
the defibrillator in case ventricular fibrillation would occur. In every patient, the usability of the iD-
System is determined according to a questionnaire focused on safety (figure 1: step 1-4, step 6). The 
questionnaire is available in attachment 4. 
 

 
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Figure 3: Instructions for use of the iD-System. 
When ventricular fibrillation of ventricular tachycardia occurs, the iD-Paddle will be applied directly to 
the heart. (figure 1: step 1-10) 
The surgeon selects the right amount of Joules, with a maximum of 50 Joules, conform to the 
defibrillator ‘LIFEPAK 20®’. The device may only be used by medical specialist and nurses, in the 
operating area. In case of internal defibrillation, extra questions  (attachment 4) focused on efficacy 
will be filled in by the surgeon. We hypothesize that in 10% of the study population, thus 10 patients 
(out of 100), ventricular fibrillation or tachycardia will occur. In this small subpopulation, the ease of 
use of the iD-Paddle and the efficacy can be tested. In case that this number is not reached, the ease 
of use of the iD-Paddle can be tested without defibrillating the patient. We will then connect the iD-
Paddle to the iD-Cable and press the iD-Paddle on the heart without pressing the ‘charge’ and ‘shock’ 
button. 
 
In case ventricular fibrillation occurs and the iD-System is not effective to restore the sinus rhythm, the 
conventional approach with use of the two paddles spoons will be performed. One paddle is placed 
behind the left ventricle, and the other is positioned over the right ventricle on the anterior surface of 
the heart, with current flowing directly through the heart. 
 
During surgery, all patients are monitored to observe possible abnormalities on ECG. As part of 
standard of care, blood samples are taken at certain time points to measure myocardial damage 
(troponin-T).  
LIFEPAK® 20 

 
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The suspected workflow is the following: 
- 
Pre-operative: evaluate inclusion- and exclusion criteria  ask for informed consent when 
meeting the criteria 
- 
Per- operative:  
o Baseline: blood sample (standard of care) 
o apply the iD-Electrode on the patient’s back 
o connect the iD-Cable to the LIFEPAK 20 defibrillator  
o connect the iD-Electrode and the iD-Paddle to the iD-Cable 
o IF defibrillation occurs: figure 4 
 
 
Figure 4: flow chart of internal defibrillation with the iD-System and, when needed, with the conventional system. 
- 
Post-operative: 
o Questionnaire ‘safety’ filled in by the surgeons who handled the device 
o IF defibrillation occurs: questionnaire ‘efficacy’ filled in by the surgeons who 
performed defibrillation with the iD-Paddle 
o For every patient: patient characteristics + small report of the surgery based on some 
questions  
o Blood sample: troponin T (standard of care) 
 
4 – 8 – 16 – 24 – 36 hours 

 
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5.3. 
Withdrawal from the study 
 
As stated in the informed consent form, patients can choose to withdraw from the study at any time 
and for any reason without any consequences.  
 
6. SAFETY AND COMPLIANCE 
6.1. 
Adverse events and serious adverse events 
 
Every adverse event (AE) defined as any undesirable experience occurring to a subject during a clinical 
trial, will be reported. No diagnosis will be made, no treatment will be initiated and no medical decision 
will be taken based on the investigated biomarker testing. In this study, the occurrence of AEs / SAEs 
will therefore be considered unrelated to the investigated biomarkers. Therefore no indirect harm 
related to the investigated POC assay in the context of this study. 
 
A ‘serious adverse event’ (SAE) is every medical occurrence or effect that results in: 
- 
death  
- 
life threatening situation 
- 
hospitalization or prolongation of existing in patients’ hospitalization  
- 
persistent or significant disability or incapacity  
- 
any other medical significant occurrence 
 
6.2. 
Compliance statements 
 
The study will be conducted in compliance to this study protocol, the current version of the Declaration 
of Helsinki, ICH GCP, and applicable local legal and regulatory requirements. 
 
Sufficient insurance coverage according to legal requirements for subjects participating in the study is 
ensured. Subjects will be informed about this and will be asked to inform the assigned investigator 
about any harm they believe to be associated with their participation in this study. 
 
Auditors, Ethics Committee, and the regulatory authorities will be granted direct access to the subject’s 
medical records to the extent permitted by the applicable law and regulation for verification of clinical 
study procedures, and/or data control, ensuring subject data confidentiality. The subject’s file and the 
source data will be archived in line with national and international legal requirements. 
 
The results of the clinical study will be documented in a clinical study report and if possible, will be 
published (e.g. in a journal or presented in a scientific meeting). 
7. STATISTICAL ANALYSIS 
As the study is mainly observational, no in-depth statistical analysis will be used. However, the patient 
population will be described via column statistics or contingency tables. 

 
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8. REFERENCES 
1.  
Punjabi PP, Taylor KM. The science and practice of cardiopulmonary bypass: From cross 
circulation to ECMO and SIRS. Glob Cardiol Sci Pract. 1 november 2013;2013(3):249–60.  
2.  
Sanjay M, Walter E. Complications of cardiac surgery. In: Edmunds LH (ed): Cardiac Surgery in the 
Adults. New York: McGraw-Hill Education; 1997. 383 p.  
3.  
Dowd FJ. Ventricular Fibrillation and Flutter. In: xPharm: The Comprehensive Pharmacology 
Reference. New York: Elsevier; 2007  p. 1–5.  
4.  
Schwartz JM, Heitmiller ES, Hunt EA, Shaffner DH. CHAPTER 38 - Cardiopulmonary Resuscitation. 
In: Davis PJ, Cladis FP, Motoyama EK, redacteuren. Smith’s Anesthesia for Infants and Children 
(Eighth Edition) Philadelphia: Mosby; 2011  p. 1200–49.  
5.  
Wouters P. Institutional report on Safety and Efficacy of the Monofib-Monoflex cardioversion 
systemTM. 2007  
6.  
Physio-Control Internal Defibrillation Handles and Electrodes Sterilization Guidelines [Internet]. 
Beschikbaar op: https://www.physio-control.com/productsupport.aspx 
7.  
Ewy GA. CHAPTER 52 - Cardiocerebral Resuscitation, Defibrillation, and Cardioversion. In: 
Jeremias A, Brown DL, redacteuren. Cardiac Intensive Care (Second Edition). Philadelphia: W.B. 
Saunders; 2010. p. 652–71.  
8.  
Rodriguez-Castro D, Farrero E, Javierre C, Carrio ML, Diaz-Prieto A, Valero J, e.a. Troponin 
repercussion of defibrillation at the end of cardiopulmonary bypass. J Card Surg. juni 
2007;22(3):192–4.  
 
9. ATTACHMENTS 
 
Attachment 1 
Clinical evaluation plan of the product 
 
Attachment 2 
Brochure of the iD-System™, One-handed Disposable Internal Defibrillation System 
 
Attachment 3 
Report of the biotechnical department 
 
Attachment 3.1 
Scan of measurement 16, 17 and 18 for verification of the report 
 
Attachment 4 
Questionnaire about safety and efficacy of the iD-System