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

Information source: Sorin Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pacing Leads Implantation

Phase: N/A

Status: Completed

Sponsored by: Sorin Group

Official(s) and/or principal investigator(s):
Henri Benkemoun, MD, Principal Investigator, Affiliation: Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France

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

Clinical Details

Official title: Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Lead dislodgment rate in acute phase

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Clinique St Pierre, Perpignan, France
Additional Information

Starting date: July 2008
Last updated: September 26, 2014

Page last updated: August 20, 2015

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