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

LivaNova

Status: Completed

Conditions: Pacing Leads Implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT01168518

RLEA01

RLEA01-FINE

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.