Ventricular ArrhythmiasPRAETORIANNCT01296022
A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
A study testing Implantation of subcutaneous ICD and Implantation of transvenous ICD in people with Ventricular Arrhythmias, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 39 sites in 6 countries.
Trial summary
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- What is being tested?
- Implantation of subcutaneous ICD and Implantation of transvenous ICD
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 39 sitesin 6 countries
- Study dates
- Feb 2011to Dec 2023
- 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 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
Netherlands14 sites
Noordwest Hospital
Alkmaar
Flevoziekenhuis
Almere Stad
Academic Medical Center - University of Amsterdam (AMC-UvA)
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
VU Medical Center
Amsterdam
Amphia Hospital
Breda
Catharina Hospital
Eindhoven
Medisch Spectrum Twente
Enschede
Medisch Centrum Leeuwarden
Leeuwarden
Maastricht University Medical Center
Maastricht
St. Antonius Hospital
Nieuwegein
Radboudumc
Nijmegen
ErasmusMC
Rotterdam
Isala Klinikum Zwolle
Zwolle
United States10 sites
Emory University Hospital
Atlanta, Georgia, 30322
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Chicago Medicine
Chicago, Illinois, 60637
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Mount SinaÏ Hospital
New York, New York, 10029
Columbia University
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
The Valley Hospital
Ridgewood, New Jersey, 07450
Germany7 sites
Herzzentrum Dresden
Dresden
Universitätsklinikum Jena
Jena
Universtätsklinikum Kiel
Kiel
Herzzentrum Leipzig
Leipzig
Universitätsklinikum Mannheim
Mannheim
University Hospital Grosshadern
Munich
Universitätsklinikum Wurzburg
Würzburg
United Kingdom6 sites
Queen Elizabeth Hospital
Birmingham
Heart & Chest Hospital
Liverpool
Hammersmith Hospital
London
Saint Bartholomew's Hospital
London
St. Georges Hospital of London
London
Oxford University Hospitals NHS Trust
Oxford
About this study
Official title: Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
Read the 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.
- Conditions
- Ventricular Arrhythmias
- Being tested
- Implantation of subcutaneous ICD, Implantation of transvenous ICD
- Keywords
- Heart rhythm disturbances, Implantable cardiac defibrillator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of subcutaneous ICDDevice
Implantation of subcutaneous ICD
Implantation of transvenous ICDDevice
Implantation of transvenous ICD
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous ICD | Active comparator | Subcutaneous Implantable Cardioverter Defibrillator Receives: Device: Implantation of subcutaneous ICD |
| Transvenous ICD | Active comparator | Transvenous Implantable Cardioverter Defibrillator Receives: Device: Implantation of transvenous ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
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.
Measured: 48 months
Secondary outcomes (13)
Number of Major Adverse Cardiac Event (MACE)
MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
Measured: 48 months
Number of appropriate shocks
An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
Measured: 48 months
Number of inappropriate shocks
Inappropriate shocks are defined as above.
Measured: 48 months
Number of complications individually
Complications are defined as above.
Measured: 48 months
Quality of life
The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
Measured: 30 months
Time to successful therapy
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.
Measured: 48 months
First shock conversion efficacy
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.
Measured: 48 months
Implant procedure time
Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
Measured: 48 months
Hospitalization rate
The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
Measured: 48 months
Fluoroscopy time
Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
Measured: 48 months
Cardiac (pre-)syncope events
Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias
Measured: 48 months
Cross-overs to the other arm
A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm
Measured: 48 months
Cardiac decompensation
Cardiac decompensation refers to acute failure of the heart to maintain adequate blood circulation for which hospitalization and medical treatment is necessary.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrhythmiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
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, Academic Medical Center - University of Amsterdam (AMC-UvA)Arthur A.M. Wilde, MD, PhD, Study chair, Academic Medical Center - University of Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296022
- Sponsor's protocol ID
- NL34725.018.10
- Other IDs
- NL34725.018.10
- Acronym
- PRAETORIAN
- Status last verified
- May 2023
- First submitted
- 12 Jan 2011
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olde Nordkamp LR, Knops RE, Bardy GH, Blaauw Y, Boersma LV, Bos JS, Delnoy PP, van Dessel PF, Driessen AH, de Groot JR, Herrman JP, Jordaens LJ, Kooiman KM, Maass AH, Meine M, Mizusawa Y, Molhoek SG, van Opstal J, Tijssen JG, Wilde AA. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart J. 2012 May;163(5):753-760.e2. doi: 10.1016/j.ahj.2012.02.012.
PubMed 22607851Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, de Wilde KC, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Tijssen JGP, Wilde AAM; PRAETORIAN Investigators. Subcutaneous or Transvenous Defibrillator Therapy. N Engl J Med. 2020 Aug 6;383(6):526-536. doi: 10.1056/NEJMoa1915932.
PubMed 32757521Knops RE, van der Stuijt W, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnet ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Clancy JF, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA; PRAETORIAN Investigatorsdouble dagger. Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial. Circulation. 2022 Feb;145(5):321-329. doi: 10.1161/CIRCULATIONAHA.121.057816. Epub 2021 Nov 14.
PubMed 34779221Knops RE, Pepplinkhuizen S, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA. Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial. Eur Heart J. 2022 Dec 14;43(47):4872-4883. doi: 10.1093/eurheartj/ehac496.
PubMed 36030464Olde Nordkamp LRA, de Veld JA, Ghani A, Kuschyk J, Bonnemeier H, Bode K, Boersma LVA, de Weger A, de Jong JSSG, Jansen WPJ, Alings M, Bijsterveld N, El-Chami MF, Beukema RJ, Vernooy K, Philbert BT, Neuzil P, Nordbeck P, van Opstal JM, Allaart CP, Wright DJ, Knaut M, Betts TR, Whinnett ZI, Lambiase PD, de Groot JR, Chicos AB, Nemirovksy D, Kaab S, Mittal S, Borger van der Burg AE, Dijkshoorn LA, Pepplinkhuizen S, van der Stuijt W, Dizon JM, Miller MA, Behr ER, Burke MC, Kooiman KM, Quast ABE, Brouwer TF, Wilde AAM, Smeding L, Knops RE; PRAETORIAN-XL Investigators. Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial. Circulation. 2025 Jul 22;152(3):172-182. doi: 10.1161/CIRCULATIONAHA.125.074576. Epub 2025 Apr 25.
PubMed 40279654Olde Nordkamp LRA, Pepplinkhuizen S, Ghani A, Boersma LVA, Kuschyk J, El-Chami MF, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Knops RE; PRAETORIAN Investigators. Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial. Circ Arrhythm Electrophysiol. 2024 Dec;17(12):e012836. doi: 10.1161/CIRCEP.124.012836. Epub 2024 Dec 3.
PubMed 39624908Knops RE, de Veld JA, Ghani A, Boersma LVA, Kuschyk J, El Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Pepplinkhuizen S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovksy D, Surber R, Upadhyay GA, Tijssen JGP, Wilde AAM, Olde Nordkamp LRA; PRAETORIAN Investigators. Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial. Circ Cardiovasc Qual Outcomes. 2024 Nov;17(11):e010822. doi: 10.1161/CIRCOUTCOMES.124.010822. Epub 2024 Nov 19.
PubMed 39561235
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
- ClinicalTrials.gov ID
- NCT01296022
- Acronym / sponsor ID
- PRAETORIAN / NL34725.018.10
- Conditions
- Ventricular Arrhythmias
- Keywords
- Heart rhythm disturbances, Implantable cardiac defibrillator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Feb 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Feb 2011 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous ICD | Active comparator | Device: Implantation of subcutaneous ICDSubcutaneous Implantable Cardioverter Defibrillator |
| Transvenous ICD | Active comparator | Device: Implantation of transvenous ICDTransvenous Implantable Cardioverter Defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Implantation of subcutaneous ICDImplantation of subcutaneous ICD | Device | Subcutaneous ICD |
| Implantation of transvenous ICDImplantation of transvenous ICD | Device | Transvenous ICD |
Primary outcome
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
Time frame: 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.
13 secondary outcomes
Number of Major Adverse Cardiac Event (MACE)
Time frame: 48 months
Number of appropriate shocks
Time frame: 48 months
Number of inappropriate shocks
Time frame: 48 months
Number of complications individually
Time frame: 48 months
Quality of life
Time frame: 30 months
Time to successful therapy
Time frame: 48 months
First shock conversion efficacy
Time frame: 48 months
Implant procedure time
Time frame: 48 months
Hospitalization rate
Time frame: 48 months
Fluoroscopy time
Time frame: 48 months
Cardiac (pre-)syncope events
Time frame: 48 months
Cross-overs to the other arm
Time frame: 48 months
Cardiac decompensation
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 22607851Olde Nordkamp LR, Knops RE, Bardy GH, Blaauw Y, Boersma LV, Bos JS, Delnoy PP, van Dessel PF, Driessen AH, de Groot JR, Herrman JP, Jordaens LJ, Kooiman KM, Maass AH, Meine M, Mizusawa Y, Molhoek SG, van Opstal J, Tijssen JG, Wilde AA. Rationale and design of the PRAETORIAN trial: a Prospective, RAndomizEd comparison of subcuTaneOus and tRansvenous ImplANtable cardioverter-defibrillator therapy. Am Heart J. 2012 May;163(5):753-760.e2. doi: 10.1016/j.ahj.2012.02.012.
- Results publication: PubMed 32757521Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, de Wilde KC, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Tijssen JGP, Wilde AAM; PRAETORIAN Investigators. Subcutaneous or Transvenous Defibrillator Therapy. N Engl J Med. 2020 Aug 6;383(6):526-536. doi: 10.1056/NEJMoa1915932.
- Results publication: PubMed 34779221Knops RE, van der Stuijt W, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, Smeding L, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnet ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Clancy JF, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA; PRAETORIAN Investigatorsdouble dagger. Efficacy and Safety of Appropriate Shocks and Antitachycardia Pacing in Transvenous and Subcutaneous Implantable Defibrillators: Analysis of All Appropriate Therapy in the PRAETORIAN Trial. Circulation. 2022 Feb;145(5):321-329. doi: 10.1161/CIRCULATIONAHA.121.057816. Epub 2021 Nov 14.
- Results publication: PubMed 36030464Knops RE, Pepplinkhuizen S, Delnoy PPHM, Boersma LVA, Kuschyk J, El-Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Olde Nordkamp LRA. Device-related complications in subcutaneous versus transvenous ICD: a secondary analysis of the PRAETORIAN trial. Eur Heart J. 2022 Dec 14;43(47):4872-4883. doi: 10.1093/eurheartj/ehac496.
- Derived from this study: PubMed 40279654Olde Nordkamp LRA, de Veld JA, Ghani A, Kuschyk J, Bonnemeier H, Bode K, Boersma LVA, de Weger A, de Jong JSSG, Jansen WPJ, Alings M, Bijsterveld N, El-Chami MF, Beukema RJ, Vernooy K, Philbert BT, Neuzil P, Nordbeck P, van Opstal JM, Allaart CP, Wright DJ, Knaut M, Betts TR, Whinnett ZI, Lambiase PD, de Groot JR, Chicos AB, Nemirovksy D, Kaab S, Mittal S, Borger van der Burg AE, Dijkshoorn LA, Pepplinkhuizen S, van der Stuijt W, Dizon JM, Miller MA, Behr ER, Burke MC, Kooiman KM, Quast ABE, Brouwer TF, Wilde AAM, Smeding L, Knops RE; PRAETORIAN-XL Investigators. Device-Related Complications in Transvenous Versus Subcutaneous Defibrillator Therapy During Long-Term Follow-Up: The PRAETORIAN-XL Trial. Circulation. 2025 Jul 22;152(3):172-182. doi: 10.1161/CIRCULATIONAHA.125.074576. Epub 2025 Apr 25.
- Derived from this study: PubMed 39624908Olde Nordkamp LRA, Pepplinkhuizen S, Ghani A, Boersma LVA, Kuschyk J, El-Chami MF, Behr ER, Brouwer TF, Kaab S, Mittal S, Quast ABE, van der Stuijt W, Smeding L, de Veld JA, Tijssen JGP, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovsky D, Surber R, Upadhyay GA, Weiss R, de Weger A, Wilde AAM, Knops RE; PRAETORIAN Investigators. Inappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial. Circ Arrhythm Electrophysiol. 2024 Dec;17(12):e012836. doi: 10.1161/CIRCEP.124.012836. Epub 2024 Dec 3.
- Derived from this study: PubMed 39561235Knops RE, de Veld JA, Ghani A, Boersma LVA, Kuschyk J, El Chami MF, Bonnemeier H, Behr ER, Brouwer TF, Kaab S, Mittal S, Pepplinkhuizen S, Quast ABE, Smeding L, van der Stuijt W, de Weger A, Bijsterveld NR, Richter S, Brouwer MA, de Groot JR, Kooiman KM, Lambiase PD, Neuzil P, Vernooy K, Alings M, Betts TR, Bracke FALE, Burke MC, de Jong JSSG, Wright DJ, Jansen WPJ, Whinnett ZI, Nordbeck P, Knaut M, Philbert BT, van Opstal JM, Chicos AB, Allaart CP, Borger van der Burg AE, Dizon JM, Miller MA, Nemirovksy D, Surber R, Upadhyay GA, Tijssen JGP, Wilde AAM, Olde Nordkamp LRA; PRAETORIAN Investigators. Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial. Circ Cardiovasc Qual Outcomes. 2024 Nov;17(11):e010822. doi: 10.1161/CIRCOUTCOMES.124.010822. Epub 2024 Nov 19.
Related trials for Ventricular Arrhythmias
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
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
Academic Medical Center - University of Amsterdam (AMC-UvA)
Arthur A.M. Wilde, MD, PhD study chair
Academic Medical Center - University of Amsterdam (AMC-UvA)
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of subcutaneous ICD and Implantation of transvenous ICD in people with Ventricular Arrhythmias, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 39 sites in 6 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Netherlands, United States, Germany, United Kingdom, Czechia and 1 more country. 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?
Results are not available in the source record.
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?
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events (time frame: 48 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 NCT01296022, which also lists 7 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 9 May 2023.