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| ID | Type | Description | Link |
|---|---|---|---|
| RLEA01 |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Lead dislodgment rate in acute phase | Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04% | Lead dislodgment |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient implanted with an endocavitary pacing lead (atrial and/or ventricular) connected to a single, double or triple chamber pacemaker or defibrillator.
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| Name | Affiliation | Role |
|---|---|---|
| Henri Benkemoun, MD | Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique St Pierre | Perpignan | Perpignan | France |
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