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
  Purpose

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


Condition Intervention
Ventricular Arrhythmias
Device: Implantation of subcutaneous ICD
Device: Implantation of transvenous ICD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 850
Study Start Date: February 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcutaneous ICD
Subcutaneous Implantable Cardioverter Defibrillator
Device: Implantation of subcutaneous ICD
Implantation of subcutaneous ICD
Active Comparator: Transvenous ICD
Transvenous Implantable Cardioverter Defibrillator
Device: Implantation of transvenous ICD
Implantation of 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296022

Contacts
Contact: Reinoud E Knops, MD +31205667731 r.e.knops@amc.nl
Contact: Louise R Olde Nordkamp, MD +31205667731 l.r.oldenordkamp@amc.nl

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: H Hoegh Petersen, MD, PhD         
Principal Investigator: H. Hoegh Petersen, MD, PhD         
Germany
University Hospital Grosshadern Recruiting
Munich, Germany
Contact: S Kääb, MD, PhD         
Principal Investigator: S. Kääb, MD, PhD         
Netherlands
Flevoziekenhuis Recruiting
Almere, Netherlands
Contact: N.R. Bijsterveld, MD, PhD         
Principal Investigator: N. R. Bijsterveld, MD, PhD         
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Netherlands
Contact: J. J. de Jong, MD, PhD         
Principal Investigator: J. J. de Jong, MD, PhD         
Academic Medical Center - University of Amsterdam (AMC-UvA) Recruiting
Amsterdam, Netherlands
Contact: Reinoud E Knops, MD    +31205667731    r.e.knops@amc.nl   
Contact: Lonneke Smeding, PhD    +31205665424    l.smeding@amc.nl   
Principal Investigator: Reinoud E Knops, MD         
Sub-Investigator: Louise R Olde Nordkamp, MD         
Amphia Hospital Recruiting
Breda, Netherlands
Contact: A. M. Alings, MD, PhD         
Principal Investigator: A. M. Alings, MD, PhD         
Catharina Hospital Recruiting
Eindhoven, Netherlands
Contact: F. A. Bracke, MD, PhD         
Principal Investigator: F. A. Bracke, MD, PhD         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: J. van Opstal, MD, PhD         
Principal Investigator: J. van Opstal, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: A. H. Maass, MD, PhD         
Principal Investigator: A. H. Maass, MD, PhD         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: K. Vernooy         
Principal Investigator: K. Vernooy, MD, PhD         
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: L. V. Boersma, MD, PhD         
Principal Investigator: L. V. Boersma, MD, PhD         
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: M. A. Brouwer, MS, PhD         
Principal Investigator: M. A. Brouwer, MD, PhD         
ErasmusMC Recruiting
Rotterdam, Netherlands
Contact: L Dabiri Abkenari, MD         
Principal Investigator: L Dabiri Abkenari, MD         
Isala Klinikum Zwolle Recruiting
Zwolle, Netherlands
Contact: P. P. Delnoy, MD, PhD         
Principal Investigator: P. P. Delnoy, MD, PhD         
United Kingdom
St. Georges Hospital of London Recruiting
London, United Kingdom
Contact: E. R. Behr, MD, PhD         
Principal Investigator: E. R. Behr, MD, PhD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Boston Scientific Corporation
Investigators
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)
  More Information

Publications:
Responsible Party: R.E. Knops, Drs. R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01296022     History of Changes
Other Study ID Numbers: NL34725.018.10, NL34725.018.10
Study First Received: January 12, 2011
Last Updated: March 19, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Heart rhythm disturbances
Implantable cardiac defibrillator

ClinicalTrials.gov processed this record on September 29, 2014