An Observational Study on the Sorin Group New Brady Leads XFine and Beflex
- Conditions
- Pacing Leads Implantation
- Registration Number
- NCT01168518
- Lead Sponsor
- LivaNova
- 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 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2254
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lead dislodgment rate in acute phase Lead dislodgment Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinique St Pierre
🇫🇷Perpignan, France