Ventricular ArrythmiaPRAETORIAN-DFTNCT03495297
A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
A study testing ommitence of defibrillation testing in people with Ventricular Arrythmia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 32 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- ommitence of defibrillation testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 965 participants
- Where
- 32 sitesin 4 countries
- Study dates
- 7 May 2018to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 4 countries.
32 sites in 4 countries
Netherlands11 sites
Flevoziekenhuis
Almere Stad
Academic Medical Center Amsterdam
Amsterdam
OLVG
Amsterdam
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Ziekenhuis
Eindhoven
UMCG
Groningen
Spaarne Gasthuis
Haarlem
Medisch Centrum Leeuwarden
Leeuwarden
St Antonius Ziekenhuis
Nieuwegein
Canisius Wilhelmina Ziekenhuis
Nijmegen
Isala Klinieken
Zwolle
United Kingdom9 sites
Basildon and Thurrock Univerity Hospital NHS Foundation Trust
Basildon
Blackpool Victoria Hospital NHS Foundation Trust
Blackpool
Royal Papworth Hospital NHS Foundation Trust
Cambridge
Heart and Chest Hospital NHS Foundation Trust
Liverpool
Barts Health NHS Trust of the Royal London Hospital
London, EC1A 7BE
Manchester Heart Center, Manchester Royal Infirmary
Manchester, M13 9WL
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
Sheffield
The Royal Wolverhampton NHS Trust, the New Cross Hospital
Wolverhampton
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30322
Erlanger Health System
Chattanooga, Tennessee, 37403
CorVita Science Foundation
Chicago, Illinois, 60605
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Mount Sinai Beth Israel
New York, New York, 10003
Icahn School of Medicine at Mount Sinaï
New York, New York, 10029
Adventh Health System
Orlando, Florida, 32803
Germany5 sites
Asklepios Kliniken
Hamburg
Universitätsklinikum Schleswig-Holstein
Kiel
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck
Universitätsklinikum Mannheim
Mannheim
Universitätsklinikum Würzburg
Würzburg
About this study
Official title: A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
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.
Read the 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.
- Conditions
- Ventricular Arrythmia
- Being tested
- ommitence of defibrillation testing
- Keywords
- subcutaneous implantable cardioverter defibrillator, Defibrillation testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ommitence of defibrillation testingProcedure or surgery
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted
| Study group | Role | What they receive |
|---|---|---|
| S-ICD Implant with defibrillation test | No intervention | Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant |
| S-ICD Implant without defibrillation test | Experimental | Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant Receives: Procedure: ommitence of defibrillation testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failed first appropriate shock in a spontaneous episode
Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode
Measured: 40 months
Secondary outcomes (20)
DFT related complications
Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT
Measured: 24 hours or 30 days
PRAETORIAN Score
Implant position will be scored using the PRAETORIAN score
Measured: up to 24 hours
Pain post implant
Pain score measured with McGill questionnaire
Measured: 1-4 hours post implant
Appropriate ICD therapy
Shocks given for VT or VF
Measured: 40 months
Inappropriate ICD therapy
Shocks given for anything else than VT or VF
Measured: 40 months
Overall DFT conversion success
The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery
Measured: 40 months
Successful DFT
A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery.
Measured: 40 months
Time to therapy
Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds.
Measured: 40 months
Time to succesful therapy
Time to successful therapy is the time between the start of VT or VF until the first successful shock.
Measured: 40 months
Shock efficacy
Percentage of appropriate shocks that was successfull
Measured: 40 months
Conversion efficacy within 5 shocks in spontaneous episodes
Conversion efficacy within 5 shocks in spontaneous episodes
Measured: 40 months
S-ICD related complications
S-ICD related complications requiring invasive intervention
Measured: 40 months
MACE post DFT
Number of Major Adverse Cardiac Events after DFT procedure
Measured: 30 days
Cardiac (pre-)syncope
Number of episodes of cardiac (pre-)syncope
Measured: 40 months
Cardiac decompensation
Number of episodes of cardiac decompensation
Measured: 40 months
Mortality
All cause mortality; arrhythmic death; cardiovascular death; unexplained death
Measured: 40 months
Length of hospitalization
Length of hospitalization post implant (nights)
Measured: 40 months
Device or lead repositioning
Number of procedures for device or lead repositioning
Measured: 40 months
ICD related infection
Number of infections related to implanted ICD
Measured: 40 months
Composite complications 30 days after implant
Number of patients experiencing complications occurring within 30 days after implant
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start7 May 2018
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 965 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Reinoud E Knops, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495297
- Sponsor's protocol ID
- NL64634_018_18
- Acronym
- PRAETORIAN-DFT
- Status last verified
- Jun 2026
- First submitted
- 23 Mar 2018
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31220775Knops RE, El-Chami MF, Marquie C, Nordbeck P, Quast ABE, Tilz RR, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Pepplinkhuizen S, de Veld JA, de Weger A, Bracke FALE, Manyam H, Probst V, Betts TR, Bijsterveld NR, Defaye P, Demming T, Elders J, Field DC, Ghani A, Golovchiner G, de Jong JSSG, Lewis N, Marijon E, Martin CA, Miller MA, Shaik NA, van der Stuijt W, Kuschyk J, Olde Nordkamp LRA, Arya A, Borger van der Burg AE, Boveda S, van Doorn DJ, Glikson M, Kaiser L, Maass AH, van Woerkens LJPM, Zaidi A, Wilde AAM, Smeding L. Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial. Heart Rhythm. 2024 Jun;21(6):836-844. doi: 10.1016/j.hrthm.2024.02.005. Epub 2024 Feb 8.
PubMed 38336193de Veld JA, Smeding L, El-Chami MF, Marquie C, Nordbeck P, Quast ABE, Tilz RR, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Pepplinkhuizen S, Dijkshoorn LA, de Weger A, Manyam H, Probst V, Betts TR, Bijsterveld NR, Defaye P, Elders J, Golovchiner G, de Jong JSSG, Lewis N, Marijon E, Martin CA, Miller MA, Shaik NA, van der Stuijt W, Kuschyk J, Olde Nordkamp LRA, Arya A, Borger van der Burg AE, Boveda S, Glikson M, Kaiser L, Maass AH, van Woerkens LJPM, Zaidi A, Wilde AAM, Knops RE. Pain after subcutaneous implantable cardioverter-defibrillator implantation: A secondary analysis of the PRAETORIAN-DFT trial. Heart Rhythm O2. 2025 Mar 31;6(6):799-807. doi: 10.1016/j.hroo.2025.03.011. eCollection 2025 Jun.
PubMed 40717858Knops RE, Marquie C, Nordbeck P, Tilz RR, Dijkshoorn LA, Quast ABE, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Betts TR, Probst V, Manyam H, Bracke FALE, Bonnemeier H, Kuschyk J, Golovchiner G, de Weger A, Miller MA, de Jong JSSG, Ghani A, Lewis N, Marijon E, Bijsterveld NR, Defaye P, Martin CA, Field DC, Elders J, Shaik NA, Boveda S, van der Stuijt W, de Veld JA, Kooiman KM, Pepplinkhuizen S, Kaiser L, Arya A, Tukkie R, van Woerkens LJPM, Feenema-Aardema MW, Glikson M, Maass AH, Zaidi A, Wilde AAM, Olde Nordkamp LRA, Smeding L, El-Chami MF; PRAETORIAN-DFT Investigators. Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial. Circulation. 2026 Aug 11;154(6):520-531. doi: 10.1161/CIRCULATIONAHA.126.080638. Epub 2026 Apr 25.
PubMed 42033346de Veld JA, El-Chami MF, Marquie C, Lambiase PD, Boersma LVA, Burke MC, de Weger A, Dijkshoorn LA, Hosny M, Betts TR, Miller MA, Kuschyk J, Bonnemeier H, Olde Nordkamp LRA, Boveda S, Wilde AAM, Smeding L, Knops RE. The Predictive Value of Impedance for Defibrillation Success After S-ICD Implantation: A Reliable Indicator? JACC Clin Electrophysiol. 2026 Jun 11:S2405-500X(26)00451-2. doi: 10.1016/j.jacep.2026.05.004. Online ahead of print.
PubMed 42283664
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
- ClinicalTrials.gov ID
- NCT03495297
- Acronym / sponsor ID
- PRAETORIAN-DFT / NL64634_018_18
- Conditions
- Ventricular Arrythmia
- Keywords
- subcutaneous implantable cardioverter defibrillator, Defibrillation testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 965 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 7 May 2018 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ICD Implant with defibrillation test | No intervention | –Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant |
| S-ICD Implant without defibrillation test | Experimental | Procedure: ommitence of defibrillation testingPatients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ommitence of defibrillation testingInduction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted | Procedure or surgery | S-ICD Implant without defibrillation test |
Primary outcome
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
20 secondary outcomes
DFT related complications
Time frame: 24 hours or 30 days
PRAETORIAN Score
Time frame: up to 24 hours
Pain post implant
Time frame: 1-4 hours post implant
Appropriate ICD therapy
Time frame: 40 months
Inappropriate ICD therapy
Time frame: 40 months
Overall DFT conversion success
Time frame: 40 months
Successful DFT
Time frame: 40 months
Time to therapy
Time frame: 40 months
Time to succesful therapy
Time frame: 40 months
Shock efficacy
Time frame: 40 months
Conversion efficacy within 5 shocks in spontaneous episodes
Time frame: 40 months
S-ICD related complications
Time frame: 40 months
MACE post DFT
Time frame: 30 days
Cardiac (pre-)syncope
Time frame: 40 months
Cardiac decompensation
Time frame: 40 months
Mortality
Time frame: 40 months
Length of hospitalization
Time frame: 40 months
Device or lead repositioning
Time frame: 40 months
ICD related infection
Time frame: 40 months
Composite complications 30 days after implant
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 31220775Quast 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.
- Results publication: PubMed 38336193Knops RE, El-Chami MF, Marquie C, Nordbeck P, Quast ABE, Tilz RR, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Pepplinkhuizen S, de Veld JA, de Weger A, Bracke FALE, Manyam H, Probst V, Betts TR, Bijsterveld NR, Defaye P, Demming T, Elders J, Field DC, Ghani A, Golovchiner G, de Jong JSSG, Lewis N, Marijon E, Martin CA, Miller MA, Shaik NA, van der Stuijt W, Kuschyk J, Olde Nordkamp LRA, Arya A, Borger van der Burg AE, Boveda S, van Doorn DJ, Glikson M, Kaiser L, Maass AH, van Woerkens LJPM, Zaidi A, Wilde AAM, Smeding L. Predictive value of the PRAETORIAN score for defibrillation test success in patients with subcutaneous ICD: A subanalysis of the PRAETORIAN-DFT trial. Heart Rhythm. 2024 Jun;21(6):836-844. doi: 10.1016/j.hrthm.2024.02.005. Epub 2024 Feb 8.
- Results publication: PubMed 40717858de Veld JA, Smeding L, El-Chami MF, Marquie C, Nordbeck P, Quast ABE, Tilz RR, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Pepplinkhuizen S, Dijkshoorn LA, de Weger A, Manyam H, Probst V, Betts TR, Bijsterveld NR, Defaye P, Elders J, Golovchiner G, de Jong JSSG, Lewis N, Marijon E, Martin CA, Miller MA, Shaik NA, van der Stuijt W, Kuschyk J, Olde Nordkamp LRA, Arya A, Borger van der Burg AE, Boveda S, Glikson M, Kaiser L, Maass AH, van Woerkens LJPM, Zaidi A, Wilde AAM, Knops RE. Pain after subcutaneous implantable cardioverter-defibrillator implantation: A secondary analysis of the PRAETORIAN-DFT trial. Heart Rhythm O2. 2025 Mar 31;6(6):799-807. doi: 10.1016/j.hroo.2025.03.011. eCollection 2025 Jun.
- Results publication: PubMed 42033346Knops RE, Marquie C, Nordbeck P, Tilz RR, Dijkshoorn LA, Quast ABE, Brouwer TF, Lambiase PD, Cassidy CJ, Boersma LVA, Burke MC, Betts TR, Probst V, Manyam H, Bracke FALE, Bonnemeier H, Kuschyk J, Golovchiner G, de Weger A, Miller MA, de Jong JSSG, Ghani A, Lewis N, Marijon E, Bijsterveld NR, Defaye P, Martin CA, Field DC, Elders J, Shaik NA, Boveda S, van der Stuijt W, de Veld JA, Kooiman KM, Pepplinkhuizen S, Kaiser L, Arya A, Tukkie R, van Woerkens LJPM, Feenema-Aardema MW, Glikson M, Maass AH, Zaidi A, Wilde AAM, Olde Nordkamp LRA, Smeding L, El-Chami MF; PRAETORIAN-DFT Investigators. Subcutaneous Defibrillator Implantation With or Without Defibrillation Test: The Primary Results of the Randomized PRAETORIAN-DFT Trial. Circulation. 2026 Aug 11;154(6):520-531. doi: 10.1161/CIRCULATIONAHA.126.080638. Epub 2026 Apr 25.
- Derived from this study: PubMed 42283664de Veld JA, El-Chami MF, Marquie C, Lambiase PD, Boersma LVA, Burke MC, de Weger A, Dijkshoorn LA, Hosny M, Betts TR, Miller MA, Kuschyk J, Bonnemeier H, Olde Nordkamp LRA, Boveda S, Wilde AAM, Smeding L, Knops RE. The Predictive Value of Impedance for Defibrillation Success After S-ICD Implantation: A Reliable Indicator? JACC Clin Electrophysiol. 2026 Jun 11:S2405-500X(26)00451-2. doi: 10.1016/j.jacep.2026.05.004. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinoud E Knops, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
32 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ommitence of defibrillation testing in people with Ventricular Arrythmia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 32 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Netherlands, United Kingdom, United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failed first appropriate shock in a spontaneous episode (time frame: 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495297, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.