Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients (ASAP)

MicroPort

Status: Terminated

Conditions: Ventricular Arrythmias

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01169246

RTGX02

RTGX02-ASAP

Details and patient eligibility

About

Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

Full description

The efficacy rate of the ATP Auto-switch function, defined as the % of VT episodes successfully reduced, will be compared with 85%.

Enrollment: 1,254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has been implanted (primo implantation or replacement) with an ICD model PARADYM VR 8250, DR 8550, CRT 8750, CRT 8770 models or any similar or higher range device
• ATP Auto-switch function is programmed ON

Exclusion criteria

• Presence of a contra-indication to the ICD therapy
• Life expectancy less than 12 months

Trial design

1,254 participants in 1 patient group

Paradym VR, DR and CRT models