Status:
COMPLETED
An Observational Study on the Sorin Group New Brady Leads XFine and Beflex
Lead Sponsor:
LivaNova
Conditions:
Pacing Leads Implantation
Eligibility:
All Genders
18+ years
Brief 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...
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. Asse...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
2254 Patients enrolled
Trial Details
Trial ID
NCT01168518
Start Date
July 1 2008
End Date
September 1 2014
Last Update
September 29 2014
Active Locations (1)
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1
Clinique St Pierre
Perpignan, Perpignan, France