CompletedNot Applicable

A Randomised Trial of S-ICD Implantation With and Without Defibrillation Testing

United States, Germany, Netherlands965 participantsStarted 2018-05-07

Plain-language summary

This study will test the hypothesis that implantation of a subcutaneous implantable cardioverter defibrillator (S-ICD) without performing a defibrillation test is non-inferior to S-ICD implant with a defibrillation test with regards to the primary endpoint failed first shock in a spontaneous arrhythmia episode when implant position is confirmed with PRAETORIAN score.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who meet current guidelines for ICD therapy and intent to undergo a de novo implant procedure for an S-ICD * Patients must pass S-ICD screening per local routine * Patients over 18 years of age, willing and capable to give informed consent * Patients must be willing and capable of complying to follow up visits * Patient must be eligible for either DFT strategy per physician discretion Exclusion Criteria: * Patient with a life expectancy shorter than 12 months due to any medical condition * Patients known to be pregnant * Patients with intracardiac thrombus * Patients with atrial fibrillation without appropriate anticoagulation * Patients likely to undergo heart transplant within 12 months * Patients with LVAD * Patients with other contra-indications for DFT per physician's discretion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Failed first appropriate shock in a spontaneous episode

Timeframe: 40 months

Trial details

NCT IDNCT03495297

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Ventricular Arrythmia trials