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NCT01169896 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

— FIRST  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01169896
Other study ID # RTGX01
Secondary ID
Status Completed
Phase N/A
First received July 22, 2010
Last updated December 2, 2015
Start date November 2007
Est. completion date December 2011

Study information
Verified date December 2015
Source LivaNova
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 616
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CCN St Denis

Sponsors (1)
Lead Sponsor Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary VT/VF episodes according to ventricular pacing (> and <50%) Device-based data 2 years No
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