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BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) \<35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement. Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
OLV Aalst
Aalst, Belgium
CH d'Annecy
Annecy, France
Hôpital de la Cavale Blanche
Brest, France
CHU Caen
Caen, France
CHU Montpied
Clermont-Ferrand, France
CH Du Bocage
Dijon, France
CHRU de Lille
Lille, France
CHU de Limoges
Limoges, France
CH Saint Philibert
Lomme, France
Cliniques du Tonkin, de la Sauvegarde et Protestante
Lyon, France
Start Date
June 9, 2015
Primary Completion Date
February 12, 2020
Completion Date
February 12, 2020
Last Updated
March 31, 2020
289
ACTUAL participants
CRT-D device replacement
DEVICE
Lead Sponsor
Biotronik SE & Co. KG
NCT06620237
NCT06488989
Data Source & Attribution
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