A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy

NCT01296022 | Unknown DMC

• 1 other identifier: NL34725.018.10
• Study Type: interventional
• Target: 850
• Locations: 6 countries
• Sites: 39

Brief Summary

This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.

Conditions

Ventricular Arrhythmias

Keywords

Heart rhythm disturbances; Implantable cardiac defibrillator

Outcome Measures

Primary Outcomes (1)

• 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.

  48 months

Secondary Outcomes (13)

• Number of Major Adverse Cardiac Event (MACE)

  48 months

• Number of appropriate shocks

  48 months

• Number of inappropriate shocks

  48 months

• Number of complications individually

  48 months

• Quality of life

  30 months

Study Arms (2)

Subcutaneous ICD

ACTIVE COMPARATOR

Subcutaneous Implantable Cardioverter Defibrillator

Device: Implantation of subcutaneous ICD

Transvenous ICD

ACTIVE COMPARATOR

Transvenous Implantable Cardioverter Defibrillator

Device: Implantation of transvenous ICD

Interventions

Implantation of subcutaneous ICD DEVICE

Implantation of subcutaneous ICD

Subcutaneous ICD

Implantation of transvenous ICD DEVICE

Implantation of transvenous ICD

Transvenous ICD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Boston Scientific Corporation: collaborator

Study Sites (39)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Mount SinaÏ Hospital

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Na Homolce Hospital

Prague, Czechia

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herzzentrum Dresden

Dresden, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universtätsklinikum Kiel

Kiel, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

University Hospital Grosshadern

Munich, Germany

Location

Universitätsklinikum Wurzburg

Würzburg, Germany

Location

Noordwest Hospital

Alkmaar, Netherlands

Location

Flevoziekenhuis

Almere Stad, Netherlands

Location

Academic Medical Center - University of Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

VU Medical Center

Amsterdam, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

ErasmusMC

Rotterdam, Netherlands

Location

Isala Klinikum Zwolle

Zwolle, Netherlands

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Heart & Chest Hospital

Liverpool, United Kingdom

Location

Hammersmith Hospital

London, United Kingdom

Location

Saint Bartholomew's Hospital

London, United Kingdom

Location

St. Georges Hospital of London

London, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 22607851 BACKGROUND

• 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.

  PMID: 32757521 RESULT

• 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.

  PMID: 34779221 RESULT

• 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.

  PMID: 36030464 RESULT

• 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.

  PMID: 40279654 DERIVED

• 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.

  PMID: 39624908 DERIVED

• 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.

  PMID: 39561235 DERIVED

Study Officials

• Reinoud E Knops, MD, PhD

  Academic Medical Center - University of Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Arthur A.M. Wilde, MD, PhD

  Academic Medical Center - University of Amsterdam (AMC-UvA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs. R.E. Knops

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

DE (7); NL (14); US (10); GB (6); DK (1); CZ (1)