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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01296022
First received: January 12, 2011
Last updated: March 19, 2014
Last verified: March 2014

January 12, 2011
March 19, 2014
February 2011
December 2017   (final data collection date for primary outcome measure)
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
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.
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01296022 on ClinicalTrials.gov Archive Site
  • Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
  • Number of appropriate shocks [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
  • Number of inappropriate shocks [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    Inappropriate shocks are defined as above.
  • Number of complications individually [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    Complications are defined as above.
  • Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
  • Time to successful therapy [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    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.
  • First shock conversion efficacy [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    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.
  • Implant procedure time [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
  • Hospitalization rate [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
  • Fluoroscopy time [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
  • Cardiac (pre-)syncope events [ Time Frame: 48 months ] [ Designated as safety issue: No ]
    Cardiac syncope is a loss of consciousness due to cerebral hypoperfusion caused by cardiac arrhythmias or presumed cardiac arrhythmias
  • Cross-overs to the other arm [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm
  • Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    MACE is defined as cardiac death, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting and/or any valve surgery
  • Number of appropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
  • Number of inappropriate shocks [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Inappropriate shocks are defined as above.
  • Number of complications individually [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
    Complications are defined as above.
  • Quality of life [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
  • Time to therapy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Time to therapy is the time between the start of VT or VF until the first shock. This includes the time of sensing and charging.
  • First shock conversion efficacy [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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.
  • Implant procedure time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Implant procedure time is the time between the first incision and placement of the last suture (skin-to-skin time).
  • Hospitalization rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    The hospitalization rate is the number of days a patient is admitted to the hospital associated with ICD implantation.
  • Fluoroscopy time [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
Not Provided
Not Provided
 
A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventricular Arrhythmias
  • Device: Implantation of subcutaneous ICD
    Implantation of subcutaneous ICD
  • Device: Implantation of transvenous ICD
    Implantation of transvenous ICD
  • Active Comparator: Subcutaneous ICD
    Subcutaneous Implantable Cardioverter Defibrillator
    Intervention: Device: Implantation of subcutaneous ICD
  • Active Comparator: Transvenous ICD
    Transvenous Implantable Cardioverter Defibrillator
    Intervention: Device: Implantation of transvenous ICD
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
June 2018
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 are unable to give informed consent
Both
18 Years and older
No
Contact: Reinoud E Knops, MD +31205667731 r.e.knops@amc.nl
Contact: Louise R Olde Nordkamp, MD +31205667731 l.r.oldenordkamp@amc.nl
Netherlands,   Denmark,   United Kingdom,   Germany
 
NCT01296022
NL34725.018.10, NL34725.018.10
Yes
R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Boston Scientific Corporation
Principal Investigator: Reinoud E Knops, MD Academic Medical Center - University of Amsterdam (AMC-UvA)
Study Chair: Arthur A.M. Wilde, MD, PhD Academic Medical Center - University of Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP