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
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 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 July 22, 2014