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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sorin Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01168518
First received: July 22, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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 Sorin Group:

Estimated Enrollment: 3116
Study Start Date: July 2008
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

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.

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168518

Contacts
Contact: Alberto BORRI 00390161487211 Alberto.borri@sorin.com

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

No publications provided

Responsible Party: BENKEMOUN, Unité de cardiologie et rythmologie interventionnelle
ClinicalTrials.gov Identifier: NCT01168518     History of Changes
Other Study ID Numbers: RLEA01-FINE, RLEA01
Study First Received: July 22, 2010
Last Updated: July 22, 2010
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

ClinicalTrials.gov processed this record on April 17, 2014