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Completed NCT03495297

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

Conditions: Ventricular Arrythmia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 965
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Location: Adventh Health System Orlando Florida

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03495297). StuddyBuddy aggregates publicly available trial information.