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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168518
First Posted: July 23, 2010
Last Update Posted: September 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
LivaNova
  Purpose

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


Condition
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 LivaNova:

Primary Outcome Measures:
  • Lead dislodgment rate in acute phase [ Time Frame: Lead dislodgment ]
    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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168518


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

Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT01168518     History of Changes
Other Study ID Numbers: RLEA01-FINE
RLEA01
First Submitted: July 22, 2010
First Posted: July 23, 2010
Last Update Posted: September 29, 2014
Last Verified: September 2014

Keywords provided by LivaNova:
Evaluate the Sorin Group new passive- and active- fixation pacing leads