A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
- Conditions
- Ventricular Arrhythmias
- Interventions
- Device: Implantation of subcutaneous ICDDevice: Implantation of transvenous ICD
- Registration Number
- NCT01296022
- Brief Summary
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 850
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subcutaneous ICD Implantation of subcutaneous ICD Subcutaneous Implantable Cardioverter Defibrillator Transvenous ICD Implantation of transvenous ICD Transvenous Implantable Cardioverter Defibrillator
- Primary Outcome Measures
Name Time Method Number of participants with implantable cardioverter defibrillator (ICD) related adverse events 48 months 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.
- Secondary Outcome Measures
Name Time Method Hospitalization rate 48 months The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
Fluoroscopy time 48 months Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
Number of Major Adverse Cardiac Event (MACE) 48 months MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
Quality of life 30 months The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
Cardiac (pre-)syncope events 48 months Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias
Time to successful therapy 48 months 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.
Cross-overs to the other arm 48 months A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm
Number of appropriate shocks 48 months An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
Number of inappropriate shocks 48 months Inappropriate shocks are defined as above.
Number of complications individually 48 months Complications are defined as above.
Implant procedure time 48 months Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
First shock conversion efficacy 48 months 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.
Cardiac decompensation 48 months Cardiac decompensation refers to acute failure of the heart to maintain adequate blood circulation for which hospitalization and medical treatment is necessary.
Trial Locations
- Locations (39)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
The University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Mount SinaÏ Hospital
🇺🇸New York, New York, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Columbia University
🇺🇸New York, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Na Homolce Hospital
🇨🇿Prague, Czechia
Rigshospitalet
🇩🇰Copenhagen, Denmark
Herzzentrum Dresden
🇩🇪Dresden, Germany
Universtätsklinikum Kiel
🇩🇪Kiel, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Germany
University Hospital Grosshadern
🇩🇪Munich, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Universitätsklinikum Wurzburg
🇩🇪Wurzburg, Germany
Noordwest Hospital
🇳🇱Alkmaar, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Academic Medical Center - University of Amsterdam (AMC-UvA)
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
VU Medical Center
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
ErasmusMC
🇳🇱Rotterdam, Netherlands
Isala Klinikum Zwolle
🇳🇱Zwolle, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Heart & Chest Hospital
🇬🇧Liverpool, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Oxford University Hospitals NHS Trust
🇬🇧Oxford, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, United Kingdom
St. Georges Hospital of London
🇬🇧London, United Kingdom
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States