An Observational Study on the Sorin Group New Brady Leads XFine and Beflex (XFine & Beflex)
This observational study is a non-interventional multi-centre, prospective study.
The aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances
Pacing Leads Implantation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice|
- Lead dislodgment rate in acute phase [ Time Frame: Lead dislodgment ] [ Designated as safety issue: Yes ]Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
|Study Start Date:||July 2008|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.
Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168518
|Clinique St Pierre|
|Principal Investigator:||Henri Benkemoun, MD||Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France|