- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495297
A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing (PRAETORIAN-DFT)
A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reinoud E Knops, MD, PhD
- Phone Number: +31205666555
- Email: r.e.knops@amc.nl
Study Contact Backup
- Name: Lonneke Schats - Smeding, PhD
- Phone Number: +31205665424
- Email: l.smeding@amc.nl
Study Locations
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Hamburg, Germany
- Asklepios Kliniken
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Kiel, Germany
- Universitätsklinikum Schleswig-Holstein
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Lübeck, Germany
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Mannheim, Germany
- Universitätsklinikum Mannheim
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Würzburg, Germany
- Universitätsklinikum Würzburg
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Almere, Netherlands
- Flevoziekenhuis
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Amsterdam, Netherlands
- OLVG
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Amsterdam, Netherlands
- Academic Medical Center Amsterdam
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Dordrecht, Netherlands
- Albert Schweitzer Ziekenhuis
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Eindhoven, Netherlands
- Catharina Ziekenhuis
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Groningen, Netherlands
- UMCG
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Haarlem, Netherlands
- Spaarne Gasthuis
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Leeuwarden, Netherlands
- Medisch Centrum Leeuwarden
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Nieuwegein, Netherlands
- St Antonius Ziekenhuis
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Nijmegen, Netherlands
- Canisius Wilhelmina Ziekenhuis
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Zwolle, Netherlands
- Isala Klinieken
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Basildon, United Kingdom
- Basildon and Thurrock Univerity Hospital NHS Foundation Trust
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Blackpool, United Kingdom
- Blackpool Victoria Hospital NHS Foundation Trust
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Cambridge, United Kingdom
- Royal Papworth Hospital NHS Foundation Trust
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Liverpool, United Kingdom
- Heart and Chest Hospital NHS Foundation Trust
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London, United Kingdom, ÉC1A 7BE
- Barts Health NHS Trust of the Royal London Hospital
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Manchester, United Kingdom, M13 9WL
- Manchester Heart Center, Manchester Royal Infirmary
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Oxford, United Kingdom, OX3 7LE
- Oxford University Hospitals NHS Foundation Trust
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Sheffield, United Kingdom
- Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
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Wolverhampton, United Kingdom
- The Royal Wolverhampton NHS Trust, the New Cross Hospital
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Florida
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Orlando, Florida, United States, 32803
- Adventh Health System
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Illinois
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Chicago, Illinois, United States, 60605
- CorVita Science Foundation
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New Jersey
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Englewood, New Jersey, United States, 07631
- Englewood Hospital and Medical Center
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, United States, 10003
- Mount Sinai Beth Israel
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Erlanger Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: S-ICD Implant with defibrillation test
Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant
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Experimental: S-ICD Implant without defibrillation test
Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
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Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failed first appropriate shock in a spontaneous episode
Time Frame: 40 months
|
Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode
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40 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DFT related complications
Time Frame: 24 hours or 30 days
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Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT
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24 hours or 30 days
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PRAETORIAN Score
Time Frame: up to 24 hours
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Implant position will be scored using the PRAETORIAN score
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up to 24 hours
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Pain post implant
Time Frame: 1-4 hours post implant
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Pain score measured with McGill questionnaire
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1-4 hours post implant
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Appropriate ICD therapy
Time Frame: 40 months
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Shocks given for VT or VF
|
40 months
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Inappropriate ICD therapy
Time Frame: 40 months
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Shocks given for anything else than VT or VF
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40 months
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Overall DFT conversion success
Time Frame: 40 months
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The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery
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40 months
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Successful DFT
Time Frame: 40 months
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A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery.
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40 months
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Time to therapy
Time Frame: 40 months
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Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds.
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40 months
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Time to succesful therapy
Time Frame: 40 months
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Time to successful therapy is the time between the start of VT or VF until the first successful shock.
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40 months
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Shock efficacy
Time Frame: 40 months
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Percentage of appropriate shocks that was successfull
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40 months
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Conversion efficacy within 5 shocks in spontaneous episodes
Time Frame: 40 months
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Conversion efficacy within 5 shocks in spontaneous episodes
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40 months
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S-ICD related complications
Time Frame: 40 months
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S-ICD related complications requiring invasive intervention
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40 months
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MACE post DFT
Time Frame: 30 days
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Number of Major Adverse Cardiac Events after DFT procedure
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30 days
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Cardiac (pre-)syncope
Time Frame: 40 months
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Number of episodes of cardiac (pre-)syncope
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40 months
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Cardiac decompensation
Time Frame: 40 months
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Number of episodes of cardiac decompensation
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40 months
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Mortality
Time Frame: 40 months
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All cause mortality; arrhythmic death; cardiovascular death; unexplained death
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40 months
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Length of hospitalization
Time Frame: 40 months
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Length of hospitalization post implant (nights)
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40 months
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Device or lead repositioning
Time Frame: 40 months
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Number of procedures for device or lead repositioning
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40 months
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ICD related infection
Time Frame: 40 months
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Number of infections related to implanted ICD
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40 months
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Composite complications 30 days after implant
Time Frame: 30 days
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Number of patients experiencing complications occurring within 30 days after implant
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30 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Reinoud E Knops, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL64634_018_18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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