An Observational Study on the Sorin Group New Brady Leads XFine and Beflex
Information source: Sorin Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pacing Leads Implantation
Sponsored by: Sorin Group
Official(s) and/or principal investigator(s):
Henri Benkemoun, MD, Principal Investigator, Affiliation: Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France
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
Official title: Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Lead dislodgment rate in acute phase
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
Assessment of electrical performances (pacing threshold, sensing amplitude, impedance) of
the leads at implant and during follow-up.
Minimum age: 18 Years.
Maximum age: N/A.
- The implanted lead must allow the measurement of pacing threshold at 0. 5ms, R-wave or
P-wave amplitude and impedance of the lead.
- Included patients may receive more than one lead under evaluation.
- Any contraindication to endocavitary lead implantation;
- Inability to understand the purpose of the study or refusal to co-operate.
- Geographically unstable or unavailability for scheduled M1-M3 follow-up at the
implanting centre as defined in the investigational plan.
- Patient of minor age (<18)
Locations and Contacts
Clinique St Pierre, Perpignan, France
Starting date: July 2008
Last updated: September 26, 2014