A Randomised Trial of S-ICD Implantation with and Without Defibrillation Testing
- Conditions
- Ventricular Arrythmia
- Interventions
- Procedure: ommitence of defibrillation testing
- Registration Number
- NCT03495297
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 965
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-ICD Implant without defibrillation test ommitence of defibrillation testing Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
- Primary Outcome Measures
Name Time Method Failed first appropriate shock in a spontaneous episode 40 months Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode
- Secondary Outcome Measures
Name Time Method PRAETORIAN Score up to 24 hours Implant position will be scored using the PRAETORIAN score
Overall DFT conversion success 40 months The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery
Length of hospitalization 40 months Length of hospitalization post implant (nights)
Appropriate ICD therapy 40 months Shocks given for VT or VF
Successful DFT 40 months A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery.
Shock efficacy 40 months Percentage of appropriate shocks that was successfull
Conversion efficacy within 5 shocks in spontaneous episodes 40 months Conversion efficacy within 5 shocks in spontaneous episodes
S-ICD related complications 40 months S-ICD related complications requiring invasive intervention
Mortality 40 months All cause mortality; arrhythmic death; cardiovascular death; unexplained death
DFT related complications 24 hours or 30 days Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT
Pain post implant 1-4 hours post implant Pain score measured with McGill questionnaire
Time to therapy 40 months Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds.
Time to succesful therapy 40 months Time to successful therapy is the time between the start of VT or VF until the first successful shock.
MACE post DFT 30 days Number of Major Adverse Cardiac Events after DFT procedure
Cardiac (pre-)syncope 40 months Number of episodes of cardiac (pre-)syncope
Device or lead repositioning 40 months Number of procedures for device or lead repositioning
ICD related infection 40 months Number of infections related to implanted ICD
Composite complications 30 days after implant 30 days Number of patients experiencing complications occurring within 30 days after implant
Inappropriate ICD therapy 40 months Shocks given for anything else than VT or VF
Cardiac decompensation 40 months Number of episodes of cardiac decompensation
Trial Locations
- Locations (32)
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
CorVita Science Foundation
🇺🇸Chicago, Illinois, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinaï
🇺🇸New York, New York, United States
Asklepios Kliniken
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Flevoziekenhuis
🇳🇱Almere, Netherlands
Academic Medical Center Amsterdam
🇳🇱Amsterdam, Netherlands
OLVG
🇳🇱Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Blackpool Victoria Hospital NHS Foundation Trust
🇬🇧Blackpool, United Kingdom
Basildon and Thurrock Univerity Hospital NHS Foundation Trust
🇬🇧Basildon, United Kingdom
Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
🇬🇧Sheffield, United Kingdom
Barts Health NHS Trust of the Royal London Hospital
🇬🇧London, United Kingdom
The Royal Wolverhampton NHS Trust, the New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Manchester Heart Center, Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Adventh Health System
🇺🇸Orlando, Florida, United States