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.
- Ventricular Arrhythmia
1 Primary · 20 Secondary · Reporting Duration: 40 months
2 Treatment Groups
S-ICD Implant with defibrillation test
1 of 2
S-ICD Implant without defibrillation test
1 of 2
965 Total Participants · 2 Treatment Groups
Primary Treatment: ommitence of defibrillation testing · No Placebo Group · N/A
Who is running the clinical trial?
Age 18+ · All Participants · 5 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Quast, Anne-Floor B.E., Sarah W.E. Baalman, Tim R. Betts, Lucas V.A. Boersma, Hendrik Bonnemeier, Serge Boveda, Tom F. Brouwer, et al.. 2019. “Rationale and Design of the PRAETORIAN-DFT Trial: A Prospective Randomized Comparative Trial of Subcutaneous Implantable Cardioverter-defibrillator Implantation with and Without Defibrillation Testing”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2019.05.002.
- R.E. Knops 2018. "A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03495297.
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
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
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