Arrythmia, Implatable Cardioverter Defibrillation, Lead Clinical Trial
Official title:
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector
The devices under investigation, NAVIGO 4LV models Pilot, 2D , and ARC are the new
quadripolar coronary venous leads with polyurethane lead body, intended to be used with
defibrillators with ventricular resynchronization therapy.
The new lead design with the presence of 4 electrodes that allows several combinations in
programming pacing vectors, is intended to benefit both the patients by improving response to
therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the
investigators by reducing the number of re-interventions needed.
This clinical investigation is a pre-market release study intended to analyze safety and
electrical performance of NAVIGO 4LV leads pre-shaped (S-shaped & U-shaped) and Straight
leads models. The primary endpoint data will be used to support the achievement of the CE
mark of NAVIGO 4LV leads.
The primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints
will be evaluated up to 2 years post-implantation. The duration of patient inclusion will be
approximately 10 months for pre-shaped NAVIGO family (S-shaped &U-shaped) and approximately
21 months for straight ones.
The post implant follows-up visits will take place at Hospital discharge, weeks 10, 6 months
and every 6 months until 2 years.
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