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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Recruiting
CT.gov ID
NCT03495297
Collaborator
Boston Scientific Corporation (Industry)
965
Enrollment
32
Locations
2
Arms
63.8
Anticipated Duration (Months)
30.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: ommitence of defibrillation testing
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Failed first appropriate shock in a spontaneous episode [40 months]

    Number of patients having experiences a failed first appropriate shock in a spontaneous arrhythmia episode

Secondary Outcome Measures

  1. DFT related complications [24 hours or 30 days]

    Number of patients experiencing DFT related complications occurring within 24h or 30 days after DFT

  2. PRAETORIAN Score [up to 24 hours]

    Implant position will be scored using the PRAETORIAN score

  3. Pain post implant [1-4 hours post implant]

    Pain score measured with McGill questionnaire

  4. Appropriate ICD therapy [40 months]

    Shocks given for VT or VF

  5. Inappropriate ICD therapy [40 months]

    Shocks given for anything else than VT or VF

  6. Overall DFT conversion success [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 [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 [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 [40 months]

    Time to successful therapy is the time between the start of VT or VF until the first successful shock.

  10. Shock efficacy [40 months]

    Percentage of appropriate shocks that was successfull

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

    Conversion efficacy within 5 shocks in spontaneous episodes

  12. S-ICD related complications [40 months]

    S-ICD related complications requiring invasive intervention

  13. MACE post DFT [30 days]

    Number of Major Adverse Cardiac Events after DFT procedure

  14. Cardiac (pre-)syncope [40 months]

    Number of episodes of cardiac (pre-)syncope

  15. Cardiac decompensation [40 months]

    Number of episodes of cardiac decompensation

  16. Mortality [40 months]

    All cause mortality; arrhythmic death; cardiovascular death; unexplained death

  17. Length of hospitalization [40 months]

    Length of hospitalization post implant (nights)

  18. Device or lead repositioning [40 months]

    Number of procedures for device or lead repositioning

  19. ICD related infection [40 months]

    Number of infections related to implanted ICD

  20. Composite complications 30 days after implant [30 days]

    Number of patients experiencing complications occurring within 30 days after implant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 other contra-indications for DFT per physician's discretion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adventh Health System Orlando Florida United States 32803
2 Emory University Hospital Atlanta Georgia United States 30322
3 CorVita Science Foundation Chicago Illinois United States 60605
4 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
5 Mount Sinai Beth Israel New York New York United States 10003
6 Icahn School of Medicine at Mount Sinaï New York New York United States 10029
7 Erlanger Health System Chattanooga Tennessee United States 37403
8 Asklepios Kliniken Hamburg Germany
9 Universitätsklinikum Schleswig-Holstein Kiel Germany
10 Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck Germany
11 Universitätsklinikum Mannheim Mannheim Germany
12 Universitätsklinikum Würzburg Würzburg Germany
13 Flevoziekenhuis Almere Netherlands
14 Academic Medical Center Amsterdam Amsterdam Netherlands
15 OLVG Amsterdam Netherlands
16 Albert Schweitzer Ziekenhuis Dordrecht Netherlands
17 Catharina Ziekenhuis Eindhoven Netherlands
18 UMCG Groningen Netherlands
19 Spaarne Gastheuis Haarlem Netherlands
20 Medisch Centrum Leeuwarden Leeuwarden Netherlands
21 St Antonius Ziekenhuis Nieuwegein Netherlands
22 Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands
23 Isala Klinieken Zwolle Netherlands
24 Basildon and Thurrock Univerity Hospital NHS Foundation Trust Basildon United Kingdom
25 Blackpool Victoria Hospital NHS Foundation Trust Blackpool United Kingdom
26 Royal Papworth Hospital NHS Foundation Trust Cambridge United Kingdom
27 Heart and Chest Hospital NHS Foundation Trust Liverpool United Kingdom
28 Barts Health NHS Trust of the Royal London Hospital London United Kingdom ÉC1A 7BE
29 Manchester Heart Center, Manchester Royal Infirmary Manchester United Kingdom M13 9WL
30 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX3 7LE
31 Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital Sheffield United Kingdom
32 The Royal Wolverhampton NHS Trust, the New Cross Hospital Wolverhampton United Kingdom

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Reinoud E Knops, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
R.E. Knops, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT03495297
Other Study ID Numbers:
  • NL64634_018_18
First Posted:
Apr 12, 2018
Last Update Posted:
Aug 10, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by R.E. Knops, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
subcutaneous implantable cardioverter defibrillator
Defibrillation testing
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 10, 2020