ventricular arrhythmias - ventricular fibrilation
Conditions
Interventions
Patients are indicated and implanted with an subcutaneous ICD. There is no
further intervention.
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for a subcutaneous ICD (EMBLEM* S-ICD or newer generation BSC S-ICD) - Left ventricular ejection fraction * 35% - A passing EMBLEM* S-ICD (or newer generation BSC S-ICD) screening ECG - Patient * 21 years of age willing and capable of giving informed consent - Patient willing and capable of complying with follow-up visits
Exclusion criteria
Exclusion criteria: - Patient with a history of spontaneous sustained VT or VF - Patient with bradycardia pacing indication - Patient eligible and scheduled for cardiac resynchronization implant - Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator) - Patient in NYHA Class IV documented in the medical records within 90 days before enrollment - Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc*) - Patient receiving hemodialysis within 180 days before to enrollment - Patients unable to give consent in person, including patients unable to read or write - Patient who is known to be pregnant or plans to become pregnant over the course of the trial - Patient unwilling or unable to cooperate with the protocol - Participation in concurrent clinical study without prior approval from Boston Scientific - Medical status (e.g., hemodynamic conditions ) of the patient doesn*t allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the Inappropriate Shock Free Rate at 18 months compared to a performance goal of 91.6%. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: - The All-Cause Shock Free Rate at 18 months compared to a performance goal of 85.8% - System and Procedure Related Complications at 30 days compared to a performance goal of 93.8%. | — |
Countries
Netherlands
Outcome results
None listed