A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
NCT ID: NCT01296022
Last Updated: 2023-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
850 participants
INTERVENTIONAL
2011-02-28
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subcutaneous ICD
Subcutaneous Implantable Cardioverter Defibrillator
Implantation of subcutaneous ICD
Implantation of subcutaneous ICD
Transvenous ICD
Transvenous Implantable Cardioverter Defibrillator
Implantation of transvenous ICD
Implantation of transvenous ICD
Interventions
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Implantation of subcutaneous ICD
Implantation of subcutaneous ICD
Implantation of transvenous ICD
Implantation of transvenous ICD
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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R.E. Knops
Drs. R.E. Knops
Principal Investigators
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Reinoud E Knops, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center - University of Amsterdam (AMC-UvA)
Arthur A.M. Wilde, MD, PhD
Role: STUDY_CHAIR
Academic Medical Center - University of Amsterdam (AMC-UvA)
Locations
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Yale-New Haven Hospital
New Haven, Connecticut, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Mount SinaÏ Hospital
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Na Homolce Hospital
Prague, , Czechia
Rigshospitalet
Copenhagen, , Denmark
Herzzentrum Dresden
Dresden, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universtätsklinikum Kiel
Kiel, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
University Hospital Grosshadern
Munich, , Germany
Universitätsklinikum Wurzburg
Würzburg, , Germany
Noordwest Hospital
Alkmaar, , Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
Academic Medical Center - University of Amsterdam (AMC-UvA)
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
VU Medical Center
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Radboudumc
Nijmegen, , Netherlands
ErasmusMC
Rotterdam, , Netherlands
Isala Klinikum Zwolle
Zwolle, , Netherlands
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Heart & Chest Hospital
Liverpool, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Saint Bartholomew's Hospital
London, , United Kingdom
St. Georges Hospital of London
London, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Countries
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References
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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.
Knops 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.
Knops 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.
Knops 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.
Olde 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.
Olde 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.
Knops 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.
Other Identifiers
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NL34725.018.10
Identifier Type: OTHER
Identifier Source: secondary_id
NL34725.018.10
Identifier Type: -
Identifier Source: org_study_id
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