Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Sorin Group Identifier:
First received: July 22, 2010
Last updated: September 26, 2014
Last verified: September 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

Pacing Leads Implantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice

Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • Lead dislodgment rate in acute phase [ Time Frame: Lead dislodgment ] [ Designated as safety issue: Yes ]
    Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%

Enrollment: 2254
Study Start Date: July 2008
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01168518

Clinique St Pierre
Perpignan, France
Sponsors and Collaborators
Sorin Group
Principal Investigator: Henri Benkemoun, MD Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France
  More Information

No publications provided

Responsible Party: Sorin Group Identifier: NCT01168518     History of Changes
Other Study ID Numbers: RLEA01-FINE, RLEA01
Study First Received: July 22, 2010
Last Updated: September 26, 2014
Health Authority: France: Ordre National des Médecins - Conseil National de l'Ordre

Keywords provided by Sorin Group:
Evaluate the Sorin Group new passive- and active- fixation pacing leads processed this record on November 25, 2014