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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01169896

Acronym

FIRST

Enrollment

616

Registered

2010-07-26

Start date

2007-11-30

Completion date

2011-12-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Fibrillation, Ventricular Tachycardia

Keywords

Impact of ventricular pacing on the incidence of VT/VF episodes for each models

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
VT/VF episodes according to ventricular pacing (> and <50%)	2 years	Device-based data

Countries

France

Outcome results