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

• ClinicalTrials.gov Identifier: NCT03495297
• Recruitment Status: Active, not recruiting
• First Posted: April 12, 2018
• Last Update Posted: May 9, 2023
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• 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: March 23, 2018
• First Posted Date: April 12, 2018
• Last Update Posted Date: May 9, 2023
• Actual Study Start Date: May 7, 2018
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 4, 2018)

• 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
• PRAETORIAN Score [ Time Frame: up to 24 hours ]
  Implant position will be scored using the PRAETORIAN score
• Pain post implant [ Time Frame: 1-4 hours post implant ]
  Pain score measured with McGill questionnaire
• Appropriate ICD therapy [ Time Frame: 40 months ]
  Shocks given for VT or VF
• Inappropriate ICD therapy [ Time Frame: 40 months ]
  Shocks given for anything else than VT or VF
• 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
• 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.
• 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.
• 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.
• Shock efficacy [ Time Frame: 40 months ]
  Percentage of appropriate shocks that was successfull
• Conversion efficacy within 5 shocks in spontaneous episodes [ Time Frame: 40 months ]
  Conversion efficacy within 5 shocks in spontaneous episodes
• S-ICD related complications [ Time Frame: 40 months ]
  S-ICD related complications requiring invasive intervention
• MACE post DFT [ Time Frame: 30 days ]
  Number of Major Adverse Cardiac Events after DFT procedure
• Cardiac (pre-)syncope [ Time Frame: 40 months ]
  Number of episodes of cardiac (pre-)syncope
• Cardiac decompensation [ Time Frame: 40 months ]
  Number of episodes of cardiac decompensation
• Mortality [ Time Frame: 40 months ]
  All cause mortality; arrhythmic death; cardiovascular death; unexplained death
• Length of hospitalization [ Time Frame: 40 months ]
  Length of hospitalization post implant (nights)
• Device or lead repositioning [ Time Frame: 40 months ]
  Number of procedures for device or lead repositioning
• ICD related infection [ Time Frame: 40 months ]
  Number of infections related to implanted ICD
• Composite complications 30 days after implant [ Time Frame: 30 days ]
  Number of patients experiencing complications occurring within 30 days after implant

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing
• Official Title: A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation With and Without DeFibrillation Testing
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Ventricular Arrythmia

Intervention

Procedure: ommitence of defibrillation testing

Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted

Study Arms

• 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
  Intervention: Procedure: ommitence of defibrillation testing

• Publications *: Quast ABE, Baalman SWE, Betts TR, Boersma LVA, Bonnemeier H, Boveda S, Brouwer TF, Burke MC, Delnoy PPHM, El-Chami M, Kuschyk J, Lambiase P, Marquie C, Miller MA, Smeding L, Wilde AAM, Knops RE. Rationale and design of the PRAETORIAN-DFT trial: A prospective randomized CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation testing. Am Heart J. 2019 Aug;214:167-174. doi: 10.1016/j.ahj.2019.05.002. Epub 2019 May 16.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 4, 2018): 965
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Eligibility 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 other contra-indications for DFT per physician's discretion

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Netherlands, United Kingdom, United States

Administrative Information

• NCT Number: NCT03495297
• Other Study ID Numbers: NL64634_018_18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Original Responsible Party: Same as current
• Current Study Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Original Study Sponsor: Same as current
• Collaborators: Boston Scientific Corporation

Investigators

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

• PRS Account: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Verification Date: May 2023