An Observational Study on the Sorin Group New Brady Leads XFine and Beflex (NCT01168518)

Study 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

Read the 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 studied

Pacing Leads Implantation

Keywords

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

In context

Lead sponsor

LivaNova is the lead sponsor of 39 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Any patient implanted with an endocavitary pacing lead (atrial and/or ventricular) connected to a single, double or triple chamber pacemaker or defibrillator.

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

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,254 participants (actual)

What researchers measure

Primary outcomes

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

Study locations

1 site

Clinique St Pierre
Perpignan, France

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01168518
Lead sponsor: LivaNova
Responsible party: Sponsor
First posted: Jul 23, 2010
Start date: Jul 2008
Primary completion: Sep 2014
Completion: Sep 2014
Last update: Sep 29, 2014

Study contacts

Henri Benkemoun, MD

principal investigator · Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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