NCT03279484

Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 317 (estimated)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Arrythmia, Implatable Cardioverter Defibrillation, Lead

Interventions

Type	Name	Description
DEVICE	NAVIGO 4LV lead implant	All patients will be attempted to implant or implanted with NAVIGO 4LV lead

Timeline

• Start date: 2017-11-24
• Primary completion: 2019-12-01
• Completion: 2022-03-01
• First posted: 2017-09-12
• Last updated: 2019-09-17

Locations

38 sites across 6 countries: France, Germany, Italy, Netherlands, Portugal, Spain