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A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing (PRAETORIAN-DFT)

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ClinicalTrials.gov Identifier: NCT03495297
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

Condition or disease Intervention/treatment Phase
Ventricular Arrythmia Procedure: ommitence of defibrillation testing Not Applicable

Detailed Description:

Implantable Cardioverter Defibrillator (ICD) implant improves survival in patients with a higher risk for sudden cardiac death. There are 2 types of ICD available; transvenous ICD (TV-ICD) and subcutaneous ICD (S-ICD). During ICD implant, defibrillation testing (DFT) is performed to test functionality of the device. However, DFT can be associated with complications such as inability to convert, complications arising from general anaesthesia, prolonged resuscitation, stroke and death. Whereas DFT may be associated with complications, the benefit of DFT is debated as literature shows there is only a modest average effect of DFT, if any, on mortality, shock efficacy or safety. Recently it was shown in a randomized controlled trial called 'SIMPLE' that routine defibrillation testing of TV-ICDs at the time of implant does not improve shock efficacy or reduce arrhythmic death. For S-ICD there is only limited data available of the effect of DFT on S-ICD efficacy. Data have however shown that the conversion efficacy of the S-ICD is comparable to TV-ICD.

DFT is currently performed in standard S-ICD implants, but is omitted in specific cases. However, an alternative method to evaluate the correct position may be desired when omitting DFT. The PRAETORIAN Score is developed using computer modelling data on factors influencing defibrillation thresholds. The PRAETORIAN score represents the chance of a patient having an elevated defibrillation threshold and consequently failing a DFT or conversion of a spontaneous arrhythmia episode. The score was retrospectively validated in two studies with 180 and 321 patients.

It was reported that most S-ICD implants are performed under general anesthesia, however other anesthesia protocols are used as well. One of the most predominant factors to use general anesthesia is the performance of the DFT. If this is omitted, other anesthesia protocols may be a good option for many patients as well.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 965 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: S-ICD Implant with defibrillation test
Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant
Experimental: S-ICD Implant without defibrillation test
Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
Procedure: ommitence of defibrillation testing
Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted




Primary Outcome Measures :
  1. Failed first appropriate shock in a spontaneous episode [ Time Frame: 40 months ]
    Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode


Secondary Outcome Measures :
  1. DFT related complications [ Time Frame: 24 hours or 30 days ]
    Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT

  2. PRAETORIAN Score [ Time Frame: up to 24 hours ]
    Implant position will be scored using the PRAETORIAN score

  3. Pain post implant [ Time Frame: 1-4 hours post implant ]
    Pain score measured with McGill questionnaire

  4. Appropriate ICD therapy [ Time Frame: 40 months ]
    Shocks given for VT or VF

  5. Inappropriate ICD therapy [ Time Frame: 40 months ]
    Shocks given for anything else than VT or VF

  6. Overall DFT conversion success [ Time Frame: 40 months ]
    The percentage of patients with at least one induced episode teminated by an S-ICD shock within five seconds post shock delivery

  7. Successful DFT [ Time Frame: 40 months ]
    A successful DFT is defined as conversion to SR or AF in less than 5 seconds from appropriate shock delivery.

  8. Time to therapy [ Time Frame: 40 months ]
    Time to therapy is the time between the start of VT or VF in a treated episode until the first shock in seconds.

  9. Time to succesful therapy [ Time Frame: 40 months ]
    Time to successful therapy is the time between the start of VT or VF until the first successful shock.

  10. Shock efficacy [ Time Frame: 40 months ]
    Percentage of appropriate shocks that was successfull

  11. Conversion efficacy within 5 shocks in spontaneous episodes [ Time Frame: 40 months ]
    Conversion efficacy within 5 shocks in spontaneous episodes

  12. S-ICD related complications [ Time Frame: 40 months ]
    S-ICD related complications requiring invasive intervention

  13. MACE post DFT [ Time Frame: 30 days ]
    Number of Major Adverse Cardiac Events after DFT procedure

  14. Cardiac (pre-)syncope [ Time Frame: 40 months ]
    Number of episodes of cardiac (pre-)syncope

  15. Cardiac decompensation [ Time Frame: 40 months ]
    Number of episodes of cardiac decompensation

  16. Mortality [ Time Frame: 40 months ]
    All cause mortality; arrhythmic death; cardiovascular death; unexplained death

  17. Length of hospitalization [ Time Frame: 40 months ]
    Length of hospitalization post implant (nights)

  18. Device or lead repositioning [ Time Frame: 40 months ]
    Number of procedures for device or lead repositioning

  19. ICD related infection [ Time Frame: 40 months ]
    Number of infections related to implanted ICD

  20. Composite complications 30 days after implant [ Time Frame: 30 days ]
    Number of patients experiencing complications occurring within 30 days after implant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD
  • Patients must pass S-ICD screening per local routine
  • Patients over 18 years of age, willing and capable to give informed consent
  • Patients must be willing and capable of complying to follow up visits
  • Patient must be eligible for either DFT strategy per physician discretion

Exclusion Criteria:

  • Patient with a life expectancy shorter than 12 months due to any medical condition
  • Patients known to be pregnant
  • Patients with intracardiac thrombus
  • Patients with atrial fibrillation without appropriate anticoagulation
  • Patients likely to undergo heart transplant within 12 months
  • Patients with LVAD
  • Patients with BMI > 40
  • Patients with other contra-indications for DFT per physician's discretion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495297


Contacts
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Contact: Reinoud E Knops, MD, PhD +31205666555 r.e.knops@amc.nl
Contact: Lonneke Smeding, PhD +31205665424 l.smeding@amc.nl

Locations
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United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mikhael F El-Chami, MD       melcham@emory.edu   
United States, Illinois
CorVita Science Foundation Recruiting
Chicago, Illinois, United States, 60605
Contact: Martin C Burke, DO       mburke@corvitahealth.org   
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Samuel Hanon, MD       samuel.hanon@mountsinai.org   
Icahn School of Medicine at Mount Sinaï Recruiting
New York, New York, United States, 10029
Contact: Marc A Miller, MD    212-241-7114    marc.miller@mountsinai.org   
Contact: Felicia Biondo       felicia.biondo@mountsinai.org   
Germany
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany
Contact: Hendrik Bonnemeier, MD       hendrik.bonnemeier@uksh.de   
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Not yet recruiting
Lübeck, Germany
Contact: Roland R. Tilz, MD         
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany
Contact: Jürgen Kuschyk, MD         
Netherlands
Flevoziekenhuis Recruiting
Almere, Netherlands
Contact: Nick Bijsterveld, MD, PhD         
Academic Medical Center Amsterdam Recruiting
Amsterdam, Netherlands
Contact: R. E. Knops, MD, PhD    +31205665555      
Contact: A. B.E. Quast, MD    +31205665555      
OLVG Recruiting
Amsterdam, Netherlands
Contact: Jonas S.S.G. de Jong, MD, PhD         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Netherlands
Contact: Frank A.L.E. Bracke, MD, PhD         
UMCG Not yet recruiting
Groningen, Netherlands
Contact: Alexander M. Maass, MD, PhD         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: Fleur A.E. Borger van der Burg, MD, PhD         
St Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Lucas V.A. Boersma, MD, PhD         
Isala Klinieken Not yet recruiting
Zwolle, Netherlands
Contact: Peter-Paul H.M. Delnoy, MD, PhD         
United Kingdom
Basildon and Thurrock Univerity Hospital NHS Foundation Trust Recruiting
Basildon, United Kingdom
Contact: Duncan C Field, MD         
Blackpool Victoria Hospital NHS Foundation Trust Recruiting
Blackpool, United Kingdom
Contact: Christopher Cassidy, MD         
Royal Papworth Hospital NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Contact: Claire Martin, MD         
Heart and Chest Hospital NHS Foundation Trust Not yet recruiting
Liverpool, United Kingdom
Contact: Jay D.J. Wright, MD         
Barts Health NHS Trust of the Royal London Hospital Recruiting
London, United Kingdom, ÉC1A 7BE
Contact: Pier D Lambiase, MD       pier.lambiase@barthhealth.nhs.uk   
Contact: Hakam Abbass       hakam.abbass@nhs.net   
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Tim R Betts, MD       tim.betts@ouh.nhs.uk   
Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Not yet recruiting
Sheffield, United Kingdom
Contact: Nigel Lewis, MD         
The Royal Wolverhampton NHS Trust, the New Cross Hospital Recruiting
Wolverhampton, United Kingdom
Contact: Anita Arya, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Boston Scientific Corporation
Investigators
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Principal Investigator: Reinoud E Knops, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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Responsible Party: R.E. Knops, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03495297     History of Changes
Other Study ID Numbers: NL64634_018_18
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
subcutaneous implantable cardioverter defibrillator
Defibrillation testing