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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01168518

Acronym

XFine & Beflex

Enrollment

2254

Registered

2010-07-23

Start date

2008-07-31

Completion date

2014-09-30

Last updated

2014-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacing Leads Implantation

Keywords

Evaluate the Sorin Group new passive- and active- fixation pacing leads

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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) * Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Lead dislodgment rate in acute phase	Lead dislodgment	Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%

Countries

France

Outcome results