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Implantable Device
S-ICD Implant Without Defibrillation Testing for Ventricular Arrhythmia (PRAETORIAN-DFT Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 months
Awards & highlights
PRAETORIAN-DFT Trial 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.
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.
PRAETORIAN-DFT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for and plan to get an S-ICD implant.
PRAETORIAN-DFT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Failed first appropriate shock in a spontaneous episode
Secondary outcome measures
Appropriate ICD therapy
Cardiac (pre-)syncope
Cardiac decompensation
+17 morePRAETORIAN-DFT 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
Who is running the clinical trial?
Boston Scientific CorporationIndustry Sponsor
718 Previous Clinical Trials
931,983 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
664 Previous Clinical Trials
2,675,920 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a left ventricular assist device (LVAD).You are expected to have a heart transplant within the next 12 months.I have atrial fibrillation and am not on blood thinners.I have a blood clot in my heart.I am willing and able to attend all follow-up visits.You have a medical condition that is expected to make your life shorter than 12 months.I am over 18 and can agree to participate in the study.My doctor agrees I can try the DFT strategy.You have other reasons that your doctor thinks make it unsafe for you to participate in the study.I am eligible for and plan to get an S-ICD implant.
Research Study Groups:
This trial has the following groups:- Group 1: S-ICD Implant without defibrillation test
- Group 2: S-ICD Implant with defibrillation test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the maximum capacity for this research endeavor?
"This clinical trial requires 965 participants that meet the designated requirements. Specifically, candidates can enroll at either CorVita Science Foundation in Chicago or Mount Sinai Beth Israel in New york City."
Answered by AI
Is there a current call for participants in this research project?
"The clinicaltrials.gov data shows that this investigation is actively accepting applicants, having first been posted on May 7th 2018 and recently modified on August 6th 2020."
Answered by AI
How many research centers are actively participating in this experiment?
"The list of 7 participating clinical sites include CorVita Science Foundation in Chicago, Mount Sinai Beth Israel in New york and Erlanger Health System in Chattanooga as well as four others."
Answered by AI
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