An Observational Study on the Sorin Group New Brady Leads XFine and Beflex (XFine & Beflex)
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|ClinicalTrials.gov Identifier: NCT01168518|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : September 29, 2014
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
|Condition or disease|
|Pacing Leads Implantation|
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.
|Study Type :||Observational|
|Actual Enrollment :||2254 participants|
|Official Title:||Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
- Lead dislodgment rate in acute phase [ Time Frame: Lead dislodgment ]Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168518
|Clinique St Pierre|
|Principal Investigator:||Henri Benkemoun, MD||Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France|