A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy

Study Overview
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Brief Summary
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This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

Detailed Description
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Background of the study: The use of implantable cardioverter defibrillators (ICDs) is an established therapy for the prevention of death from ventricular arrhythmia. Recently a new subcutaneous ICD has been introduced, eliminating the need for transvenous lead placement in or on the heart which is mandatory in the transvenous ICD. The new subcutaneous ICD therapy already proved to be feasible and safe and is an approved therapy in Europe. It is likely that the eliminated need for transvenous lead placement substantially reduces the implantation related complications and elongates lead longevity and thus reduces inappropriate shocks associated with lead fractures. On the other hand it is unclear whether the lack of capability to provide antitachy-pacing (ATP) in the subcutaneous ICD may be a limitation for patients with frequent recurrent ventricular tachycardia. This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous ICD. Objectives of the study: (1) To compare the subcutaneous ICD to the transvenous ICD for major adverse events (i.e. inappropriate shocks, acute and chronic implant related complications and lead- or device related complications). (2) To determine to which degree the lack of ATP function leads to more appropriate shocks in patients with a subcutaneous ICD. Study design: Multicenter, prospective, randomized controlled trial with either treatment with the transvenous ICD or subcutaneous ICD (1:1). Study population: 2x425 patients with class I or IIa indication for ICD therapy without an indication for pacing.

Official Title
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Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing

Conditions
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Ventricular Arrhythmias

Intervention / Treatment
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* Device: Implantation of subcutaneous ICD
* Device: Implantation of transvenous ICD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years and older Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death Exclusion Criteria: Patients with documented therapy refractory monomorphic ventricular tachycardia Patients having an indication for pacing therapy Patients with ventricular tachycardia less than 170 bpm Patients failing appropriate QRS/T-wave sensing with the S-ICD ECG patient screening tool provided by Cameron Health/Boston Scientific Patients with incessant ventricular tachycardia Patients with a serious known concomitant disease with a life expectancy of less than one year Patients with circumstances that prevent follow-up (no permanent home or address, transient, etc.) Patients who have had a previous ICD implant Patient who receive cardiac contractility modulation therapy or are likely to receive cardiac contractility modulation therapy. Patients who are unable to give informed consent

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subcutaneous ICD<br>Subcutaneous Implantable Cardioverter Defibrillator | Device: Implantation of subcutaneous ICD<br>* Implantation of subcutaneous ICD<br>|
| Active Comparator: Transvenous ICD<br>Transvenous Implantable Cardioverter Defibrillator | Device: Implantation of transvenous ICD<br>* Implantation of transvenous ICD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with implantable cardioverter defibrillator (ICD) related adverse events | ICD related adverse events are defined as inappropriate shocks and/or implant-, lead- and device related complications. An inappropriate shock is shock therapy for anything else but ventricular fibrillation or ventricular tachycardia. Implant related complications are defined as ICD related infections, ICD related bleedings, thrombotic events, need for lead reposition, post-implant pneumothorax, post-implant hematothorax, or post-implant perforation/tamponade. Lead- or device related complications are all complications related to the lead or device. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Major Adverse Cardiac Event (MACE) | MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery | 48 months | 
| Number of appropriate shocks | An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia. | 48 months | 
| Number of inappropriate shocks | Inappropriate shocks are defined as above. | 48 months | 
| Number of complications individually | Complications are defined as above. | 48 months | 
| Quality of life | The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires. | 30 months | 
| Time to successful therapy | Time to successful therapy is the time between the start of VT or VF until the first successful shock or first successful ATP episode. This includes the time of sensing and charging. | 48 months | 
| First shock conversion efficacy | First shock conversion efficacy is the amount of patients with VT or VF who are successfully converted with the first shock given by the transvenous ICD or subcutaneous ICD. | 48 months | 
| Implant procedure time | Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time). | 48 months | 
| Hospitalization rate | The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation. | 48 months | 
| Fluoroscopy time | Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD. | 48 months | 
| Cardiac (pre-)syncope events | Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias | 48 months | 
| Cross-overs to the other arm | A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm | 48 months | 
| Cardiac decompensation | Cardiac decompensation refers to acute failure of the heart to maintain adequate blood circulation for which hospitalization and medical treatment is necessary. | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rhythm disturbances, Implantable cardiac defibrillator