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