ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

Tachyarrhythmia

Treatments

Device: ICD

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231426

CR-CA-031203-M

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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