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

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ClinicalTrials.gov Identifier: NCT01296022
Recruitment Status : Active, not recruiting
First Posted : February 15, 2011
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information
First Submitted Date  ICMJE January 12, 2011
First Posted Date  ICMJE February 15, 2011
Last Update Posted Date August 10, 2020
Actual Study Start Date  ICMJE February 2011
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events [ Time Frame: 30 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2014)
  • Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 48 months ]
    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 ]
    An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
  • Number of inappropriate shocks [ Time Frame: 48 months ]
    Inappropriate shocks are defined as above.
  • Number of complications individually [ Time Frame: 48 months ]
    Complications are defined as above.
  • Quality of life [ Time Frame: 30 months ]
    The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
  • Time to successful therapy [ Time Frame: 48 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    A crossover to the other arm is defined as a patient who for any reason after randomization is switched to the other ICD arm
  • Cardiac decompensation [ Time Frame: 48 months ]
    Cardiac decompensation refers to acute failure of the heart to maintain adequate blood circulation for which hospitalization and medical treatment is necessary.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • Number of Major Adverse Cardiac Event (MACE) [ Time Frame: 30 months ]
    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 ]
    An appropriate shock is shock therapy for ventricular fibrillation or ventricular tachycardia.
  • Number of inappropriate shocks [ Time Frame: 30 months ]
    Inappropriate shocks are defined as above.
  • Number of complications individually [ Time Frame: 30 months ]
    Complications are defined as above.
  • Quality of life [ Time Frame: 30 months ]
    The quality of life is measured by the SF-36 and Duke Activity Status Index questionnaires.
  • Time to therapy [ Time Frame: 30 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    Fluoroscopy time is the total time that fluoroscopy is used during the implantation of either the transvenous ICD or subcutaneous ICD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A PRospective, rAndomizEd Comparison of subcuTaneOous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy
Official Title  ICMJE 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
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventricular Arrhythmias
Intervention  ICMJE
  • Device: Implantation of subcutaneous ICD
    Implantation of subcutaneous ICD
  • Device: Implantation of transvenous ICD
    Implantation of transvenous ICD
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2013)
850
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2011)
700
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Denmark,   Germany,   Netherlands,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01296022
Other Study ID Numbers  ICMJE NL34725.018.10
NL34725.018.10 ( Other Identifier: Centrale Commissie Mensgebonden Onderzoek )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor  ICMJE Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators  ICMJE Boston Scientific Corporation
Investigators  ICMJE
Principal Investigator: Reinoud E Knops, MD, PhD Academic Medical Center - University of Amsterdam (AMC-UvA)
Study Chair: Arthur A.M. Wilde, MD, PhD Academic Medical Center - University of Amsterdam (AMC-UvA)
PRS Account Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date August 2020

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