An interventional study of Implantation of subcutaneous ICD and Implantation of transvenous ICD in Ventricular Arrhythmias, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Active, not recruiting at 39 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's planned enrollment of 850 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Subcutaneous Implantable Cardioverter Defibrillator
Device: Implantation of subcutaneous ICD
Transvenous Implantable Cardioverter Defibrillator
Device: Implantation of transvenous ICD
Implantation of subcutaneous ICD
Implantation of transvenous ICD
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.
Time frame: 48 months
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
Time frame: 48 months
Number of appropriate shocks
An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
Time frame: 48 months
Number of inappropriate shocks
Inappropriate shocks are defined as above.
Time frame: 48 months
Number of complications individually
Complications are defined as above.
Time frame: 48 months
Quality of life
The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 48 months
Hospitalization rate
The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 48 months
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)