NCT01168518

An Observational Study on the Sorin Group New Brady Leads XFine and Beflex

Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,254 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pacing Leads Implantation

Timeline

• Start date: 2008-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2010-07-23
• Last updated: 2014-09-29

Locations

1 site across 1 country: France