Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients (FIRST)

LivaNova

Status: Completed

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT01169896

RTGX01

Details and patient eligibility

About

Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Full description

This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD & CRT-D devices and how the ICD & CRT-D devices are used in clinical practice through two years follow-up.

Enrollment: 616 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion Criteria:

•Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data)

Main exclusion Criteria:

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