A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

Study Overview
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Brief Summary
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This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

Detailed Description
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Implantable Cardioverter Defibrillator (ICD) implant improves survival in patients with a higher risk for sudden cardiac death. There are 2 types of ICD available; transvenous ICD (TV-ICD) and subcutaneous ICD (S-ICD). During ICD implant, defibrillation testing (DFT) is performed to test functionality of the device. However, DFT can be associated with complications such as inability to convert, complications arising from general anaesthesia, prolonged resuscitation, stroke and death. Whereas DFT may be associated with complications, the benefit of DFT is debated as literature shows there is only a modest average effect of DFT, if any, on mortality, shock efficacy or safety. Recently it was shown in a randomized controlled trial called 'SIMPLE' that routine defibrillation testing of TV-ICDs at the time of implant does not improve shock efficacy or reduce arrhythmic death. For S-ICD there is only limited data available of the effect of DFT on S-ICD efficacy. Data have however shown that the conversion efficacy of the S-ICD is comparable to TV-ICD. DFT is currently performed in standard S-ICD implants, but is omitted in specific cases. However, an alternative method to evaluate the correct position may be desired when omitting DFT. The PRAETORIAN Score is developed using computer modelling data on factors influencing defibrillation thresholds. The PRAETORIAN score represents the chance of a patient having an elevated defibrillation threshold and consequently failing a DFT or conversion of a spontaneous arrhythmia episode. The score was retrospectively validated in two studies with 180 and 321 patients. It was reported that most S-ICD implants are performed under general anesthesia, however other anesthesia protocols are used as well. One of the most predominant factors to use general anesthesia is the performance of the DFT. If this is omitted, other anesthesia protocols may be a good option for many patients as well.

Official Title
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A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing

Conditions
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Ventricular Arrythmia

Intervention / Treatment
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* Procedure: ommitence of defibrillation testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD Patients must pass S-ICD screening per local routine Patients over 18 years of age, willing and capable to give informed consent Patients must be willing and capable of complying to follow up visits Patient must be eligible for either DFT strategy per physician discretion Exclusion Criteria: Patient with a life expectancy shorter than 12 months due to any medical condition Patients known to be pregnant Patients with intracardiac thrombus Patients with atrial fibrillation without appropriate anticoagulation Patients likely to undergo heart transplant within 12 months Patients with LVAD Patients with other contra-indications for DFT per physician's discretion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: S-ICD Implant with defibrillation test<br>Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant | |
| Experimental: S-ICD Implant without defibrillation test<br>Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant | Procedure: ommitence of defibrillation testing<br>* Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failed first appropriate shock in a spontaneous episode | Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode | 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFT related complications | Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT | 24 hours or 30 days | 
| PRAETORIAN Score | Implant position will be scored using the PRAETORIAN score | up to 24 hours | 
| Pain post implant | Pain score measured with McGill questionnaire | 1-4 hours post implant | 
| Appropriate ICD therapy | Shocks given for VT or VF | 40 months | 
| Inappropriate ICD therapy | Shocks given for anything else than VT or VF | 40 months | 
| Overall DFT conversion success | The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery | 40 months | 
| Successful DFT | A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery. | 40 months | 
| Time to therapy | Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds. | 40 months | 
| Time to succesful therapy | Time to successful therapy is the time between the start of VT or VF until the first successful shock. | 40 months | 
| Shock efficacy | Percentage of appropriate shocks that was successfull | 40 months | 
| Conversion efficacy within 5 shocks in spontaneous episodes | Conversion efficacy within 5 shocks in spontaneous episodes | 40 months | 
| S-ICD related complications | S-ICD related complications requiring invasive intervention | 40 months | 
| MACE post DFT | Number of Major Adverse Cardiac Events after DFT procedure | 30 days | 
| Cardiac (pre-)syncope | Number of episodes of cardiac (pre-)syncope | 40 months | 
| Cardiac decompensation | Number of episodes of cardiac decompensation | 40 months | 
| Mortality | All cause mortality; arrhythmic death; cardiovascular death; unexplained death | 40 months | 
| Length of hospitalization | Length of hospitalization post implant (nights) | 40 months | 
| Device or lead repositioning | Number of procedures for device or lead repositioning | 40 months | 
| ICD related infection | Number of infections related to implanted ICD | 40 months | 
| Composite complications 30 days after implant | Number of patients experiencing complications occurring within 30 days after implant | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subcutaneous implantable cardioverter defibrillator, Defibrillation testing