Tachyarrhythmia
Conditions
Brief summary
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.
Interventions
DEVICEICD
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices * Patients who sign and date a Patient Informed Consent form prior to the implant visit * Patients who remain in the clinical care of the enrolling physician in approved centers * Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex * Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV
Exclusion criteria
* Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies * Patients who undergo lead repositioning * Patients who are expected to receive a heart transplant during the duration of the study * Patients who have or who are likely to receive a tricuspid valve prosthesis * Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study * Patients who are younger than 18 years of age * Patients who are pregnant or plan to become pregnant during the study * Patients whose life expectancy is less than 12 months * Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
Countries
United States
Outcome results
None listed