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
1 other identifier
interventional
965
4 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedStudy Start
First participant enrolled
May 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedFebruary 3, 2025
January 1, 2025
6.9 years
March 23, 2018
January 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failed first appropriate shock in a spontaneous episode
Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode
40 months
Secondary Outcomes (20)
DFT related complications
24 hours or 30 days
PRAETORIAN Score
up to 24 hours
Pain post implant
1-4 hours post implant
Appropriate ICD therapy
40 months
Inappropriate ICD therapy
40 months
- +15 more secondary outcomes
Study Arms (2)
S-ICD Implant with defibrillation test
NO INTERVENTIONPatients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant
S-ICD Implant without defibrillation test
EXPERIMENTALPatients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
Interventions
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Adventh Health System
Orlando, Florida, 32803, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
CorVita Science Foundation
Chicago, Illinois, 60605, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Icahn School of Medicine at Mount Sinaï
New York, New York, 10029, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
Asklepios Kliniken
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Flevoziekenhuis
Almere Stad, 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
Basildon and Thurrock Univerity Hospital NHS Foundation Trust
Basildon, United Kingdom
Blackpool Victoria Hospital NHS Foundation Trust
Blackpool, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust of the Royal London Hospital
London, ÉC1A 7BE, United Kingdom
Manchester Heart Center, Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield, United Kingdom
The Royal Wolverhampton NHS Trust, the New Cross Hospital
Wolverhampton, United Kingdom
Related Publications (1)
Quast ABE, Baalman SWE, Betts TR, Boersma LVA, Bonnemeier H, Boveda S, Brouwer TF, Burke MC, Delnoy PPHM, El-Chami M, Kuschyk J, Lambiase P, Marquie C, Miller MA, Smeding L, Wilde AAM, Knops RE. Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing. Am Heart J. 2019 Aug;214:167-174. doi: 10.1016/j.ahj.2019.05.002. Epub 2019 May 16.
PMID: 31220775BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Reinoud E Knops, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2018
First Posted
April 12, 2018
Study Start
May 7, 2018
Primary Completion
April 1, 2025
Study Completion
July 1, 2025
Last Updated
February 3, 2025
Record last verified: 2025-01