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Implantable Cardioverter Defibrillator
Subcutaneous ICD vs Transvenous ICD for Ventricular Arrhythmia (PRAETORIAN 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
PRAETORIAN Trial Summary
This trial will compare the two types of ICDs to see which is better.
Eligible Conditions
- Ventricular Arrhythmia
PRAETORIAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with implantable cardioverter defibrillator (ICD) related adverse events
Secondary outcome measures
Heart
Cardiac decompensation
Cross-overs to the other arm
+10 morePRAETORIAN Trial Design
2Treatment groups
Active Control
Group I: Subcutaneous ICDActive Control1 Intervention
Subcutaneous Implantable Cardioverter Defibrillator
Group II: Transvenous ICDActive Control1 Intervention
Transvenous Implantable Cardioverter Defibrillator
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Who is running the clinical trial?
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Lead Sponsor
664 Previous Clinical Trials
2,676,035 Total Patients Enrolled
4 Trials studying Ventricular Arrhythmia
11,475 Patients Enrolled for Ventricular Arrhythmia
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
932,548 Total Patients Enrolled
4 Trials studying Ventricular Arrhythmia
1,826 Patients Enrolled for Ventricular Arrhythmia
Reinoud E Knops, MD, PhDPrincipal InvestigatorAcademic Medical Center - University of Amsterdam (AMC-UvA)
2 Previous Clinical Trials
995 Total Patients Enrolled
2 Trials studying Ventricular Arrhythmia
995 Patients Enrolled for Ventricular Arrhythmia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have ongoing rapid heartbeats in the lower chambers of your heart.You have a serious illness that is expected to significantly shorten your life.You have a type of heart rhythm problem that has not responded to treatment.You need a pacemaker.Your heart is beating too fast.You do not pass the heart rhythm test using the S-ICD ECG patient screening tool provided by Cameron Health/Boston Scientific.You have had a previous implantable cardioverter-defibrillator (ICD).You are currently using or may need to use a specific type of heart treatment called cardiac contractility modulation therapy.You are 18 years old or older.You have a specific heart condition that requires a certain type of implantable device according to the 2006 heart guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Subcutaneous ICD
- Group 2: Transvenous ICD
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.
Is this medical study being conducted in various locations across the state?
"Recruitment is currently open at 10 different medical sites, including Columbus, Englewood and Ridgewood. It would be beneficial to select the closest trial site so as to minimize travel requirements if you decide to join this study."
Answered by AI
Does this experiment have any room for new participants?
"Clinicaltrials.gov confirms that this trial, first posted on February 1st 2011 and most recently updated August 6th 2020 is no longer recruiting volunteers; however, 81 other medical studies are actively enrolling research participants at the present moment."
Answered by AI
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