Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardioverter Defibrillator-Cardiac Resynchronization Therapy Defibrillator (ICD-CRTD) Patients
Recruitment status was Active, not recruiting
The primary objective of this observational study is to show that ICD VR and DR patients presenting more than 50% cumulative right ventricular pacing percentage present significantly more therapies for Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF)episodes compared to ICD patients presenting less than 50% cumulative ventricular pacing percentage during two years follow-up.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Focus on the Impact of Ventricular Pacing in Unselected Implantable Cardiac Defibrillator (ICD) - Cardiac Resynchronization Therapy (CRT) Patients|
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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 and will address the following:
Impact of ventricular pacing on patients outcome: impact of ventricular pacing on the incidence of VT/VF episodes for each models, incidence of atrial arrhythmia for each models, evolution of the cardiopathy (New York Heart Association NYHA Class, Left Ventricular Ejection Fraction LVEF), morbidity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169896
|St Denis, France|
|Principal Investigator:||Olivier Piot, MD||CCN St Denis|