heart rhythm disturbances
Conditions
Interventions
Patients will be randomised between S-ICD implant with or without 
defibrillation test.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients must be >= 18 years of age, willing and capable of giving informed consent • Patients who meet current guidelines for ICD therapy and intend to undergo a de novo implant procedure for an S-ICD. • Patients must pass S-ICD screening per local routine • Patients willing and capable of complying with follow-up visits • Patients must be eligible for both DFT strategies per physician discretion.
Exclusion criteria
Exclusion criteria: • Patients with life expectancy shorter than 12 months due to any medical condition • Patients who are 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 a BMI > 40 • Patients with other contra-indications for DFT per physician*s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of this study is the first shock efficacy in spontaneous events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include DFT related complications, PRAETORIAN Score (chest X-ray implant score), pain score at baseline and after implant, Mortality (all-cause, arrhythmic death, cardiovascular death, unexplained death), Device or lead repositioning, MACE within 30 days post-implant, successful shock (in both DFT and spontaneous events), time to (successful) therapy, inappropriate therapy, cardiac (pre-)syncope, cardiac decompensation, length of hospitalization post implant and ICD related infection. | — |
Countries
Netherlands
Outcome results
None listed