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Implantable Device

S-ICD Implant Without Defibrillation Testing for Ventricular Arrhythmia (PRAETORIAN-DFT Trial)

Haarlem, Netherlands
N/A
Waitlist Available
Led By Reinoud E Knops, MD, PhD
Research Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD
Be older than 18 years old
Must not have
Patients with atrial fibrillation without appropriate anticoagulation
Patients with intracardiac thrombus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether not testing an S-ICD before implantation is as good as testing it, in terms of the primary endpoint of failed first shock in a spontaneous arrhythmia episode.

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Who is the study for?
This trial is for adults over 18 who need a new subcutaneous implantable cardioverter defibrillator (S-ICD) and meet current guidelines for ICD therapy. They must be able to consent, follow up on visits, pass S-ICD screening, and not have conditions like heart failure devices (LVAD), short life expectancy, pregnancy, intracardiac thrombus or planned heart transplant.Check my eligibility
What is being tested?
The study compares two ways of implanting an S-ICD: one with a defibrillation test to check its function and another without the test. The main goal is to see if skipping the test does not lead to more failed first shocks during real arrhythmia episodes.See study design
What are the potential side effects?
Potential side effects are related to the S-ICD implant procedure itself rather than the presence or absence of defibrillation testing. These can include infection at the site of surgery, bleeding, bruising, discomfort or pain where the device was placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for and plan to get an S-ICD implant.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have atrial fibrillation and am not on blood thinners.
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Select...
I have a blood clot in my heart.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Failed first appropriate shock in a spontaneous episode
Secondary study objectives
Appropriate ICD therapy
Cardiac (pre-)syncope
Cardiac decompensation
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: S-ICD Implant without defibrillation testExperimental Treatment1 Intervention
Patients undergoing de novo S-ICD implantation without induction of VF and defibrillation testing post-implant
Group II: S-ICD Implant with defibrillation testActive Control1 Intervention
Patients undergoing de novo S-ICD implantation including induction of VF and defibrillation testing post-implant

Find a Location

Closest Location:CorVita Science Foundation· Chicago, IL· 275 miles

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
755 Previous Clinical Trials
865,714 Total Patients Enrolled
4 Trials studying Ventricular Arrhythmia
1,711 Patients Enrolled for Ventricular Arrhythmia
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Lead Sponsor
718 Previous Clinical Trials
2,722,884 Total Patients Enrolled
4 Trials studying Ventricular Arrhythmia
11,360 Patients Enrolled for Ventricular Arrhythmia
Reinoud E Knops, MD, PhDPrincipal InvestigatorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 Previous Clinical Trials
880 Total Patients Enrolled
2 Trials studying Ventricular Arrhythmia
880 Patients Enrolled for Ventricular Arrhythmia

Media Library

S-ICD Implantation (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT03495297 — N/A
Ventricular Arrhythmia Research Study Groups: S-ICD Implant without defibrillation test, S-ICD Implant with defibrillation test
Ventricular Arrhythmia Clinical Trial 2023: S-ICD Implantation Highlights & Side Effects. Trial Name: NCT03495297 — N/A
S-ICD Implantation (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03495297 — N/A
~0 spots leftby Apr 2025
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