ommitence of defibrillation testing for Ventricular Arrhythmia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medisch Centrum Leeuwarden, Leeuwarden, NetherlandsVentricular Arrhythmiaommitence of defibrillation testing - Procedure
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions
  • Ventricular Arrhythmia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: 40 months

1-4 hours post implant
Pain post implant
Day 30
DFT related complications
30 days
Composite complications 30 days after implant
MACE post DFT
40 months
Appropriate ICD therapy
Cardiac (pre-)syncope
Cardiac decompensation
Conversion efficacy within 5 shocks in spontaneous episodes
Device or lead repositioning
Failed first appropriate shock in a spontaneous episode
ICD related infection
Inappropriate ICD therapy
Length of hospitalization
Mortality
Overall DFT conversion success
S-ICD related complications
Shock efficacy
Successful DFT
Time to succesful therapy
Time to therapy
up to 24 hours
PRAETORIAN Score

Trial Safety

Trial Design

2 Treatment Groups

S-ICD Implant with defibrillation test
1 of 2
S-ICD Implant without defibrillation test
1 of 2

Active Control

Experimental Treatment

965 Total Participants · 2 Treatment Groups

Primary Treatment: ommitence of defibrillation testing · No Placebo Group · N/A

S-ICD Implant without defibrillation test
Procedure
Experimental Group · 1 Intervention: ommitence of defibrillation testing · Intervention Types: Procedure
S-ICD Implant with defibrillation testNoIntervention Group · 1 Intervention: S-ICD Implant with defibrillation test · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 40 months

Who is running the clinical trial?

Boston Scientific CorporationIndustry Sponsor
679 Previous Clinical Trials
919,273 Total Patients Enrolled
3 Trials studying Ventricular Arrhythmia
1,694 Patients Enrolled for Ventricular Arrhythmia
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Lead Sponsor
570 Previous Clinical Trials
2,663,682 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

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.