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

January 30, 2025 updated by: R.E. Knops, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

A Prospective Randomised CompArative Trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and Without DeFibrillation Testing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
965

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Reinoud E Knops, MD, PhD
  • Phone Number: +31205666555
  • Email: r.e.knops@amc.nl

Study Contact Backup

  • Name: Lonneke Schats - Smeding, PhD
  • Phone Number: +31205665424
  • Email: l.smeding@amc.nl

Study Locations

  • Germany
      • Hamburg, Germany
        • ASKLEPIOS Kliniken
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Würzburg, Germany
        • Universitatsklinikum Wurzburg
  • Netherlands
      • Almere, Netherlands
        • Flevoziekenhuis
      • Amsterdam, Netherlands
        • OLVG
      • Amsterdam, Netherlands
        • Academic Medical Center Amsterdam
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Groningen, Netherlands
        • UMCG
      • Haarlem, Netherlands
        • Spaarne Gasthuis
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nieuwegein, Netherlands
        • St Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • Canisius Wilhelmina Ziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken
  • United Kingdom
      • Basildon, United Kingdom
        • Basildon and Thurrock Univerity Hospital NHS Foundation Trust
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital NHS Foundation Trust
      • Cambridge, United Kingdom
        • Royal Papworth Hospital NHS Foundation Trust
      • Liverpool, United Kingdom
        • Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom, ÉC1A 7BE
        • Barts Health NHS Trust of the Royal London Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Heart Center, Manchester Royal Infirmary
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital
      • Wolverhampton, United Kingdom
        • The Royal Wolverhampton NHS Trust, the New Cross Hospital
  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Adventh Health System
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60605
        • CorVita Science Foundation
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
40 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 hours or 30 days
PRAETORIAN Score
Time Frame: up to 24 hours
Implant position will be scored using the PRAETORIAN score
up to 24 hours
Pain post implant
Time Frame: 1-4 hours post implant
Pain score measured with McGill questionnaire
1-4 hours post implant
Appropriate ICD therapy
Time Frame: 40 months
Shocks given for VT or VF
40 months
Inappropriate ICD therapy
Time Frame: 40 months
Shocks given for anything else than VT or VF
40 months
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
40 months
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.
40 months
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.
40 months
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.
40 months
Shock efficacy
Time Frame: 40 months
Percentage of appropriate shocks that was successfull
40 months
Conversion efficacy within 5 shocks in spontaneous episodes
Time Frame: 40 months
Conversion efficacy within 5 shocks in spontaneous episodes
40 months
S-ICD related complications
Time Frame: 40 months
S-ICD related complications requiring invasive intervention
40 months
MACE post DFT
Time Frame: 30 days
Number of Major Adverse Cardiac Events after DFT procedure
30 days
Cardiac (pre-)syncope
Time Frame: 40 months
Number of episodes of cardiac (pre-)syncope
40 months
Cardiac decompensation
Time Frame: 40 months
Number of episodes of cardiac decompensation
40 months
Mortality
Time Frame: 40 months
All cause mortality; arrhythmic death; cardiovascular death; unexplained death
40 months
Length of hospitalization
Time Frame: 40 months
Length of hospitalization post implant (nights)
40 months
Device or lead repositioning
Time Frame: 40 months
Number of procedures for device or lead repositioning
40 months
ICD related infection
Time Frame: 40 months
Number of infections related to implanted ICD
40 months
Composite complications 30 days after implant
Time Frame: 30 days
Number of patients experiencing complications occurring within 30 days after implant
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Reinoud E Knops, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL64634_018_18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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