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

MicroPort

Status

Unknown

Conditions

Arrythmia, Implatable Cardioverter Defibrillation, Lead

Treatments

Device: NAVIGO 4LV lead implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT03279484

LCPL01

Details and patient eligibility

About

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

Full 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.

Enrollment

317 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any patient presenting a CRT-D indication as detailed in the ESC guidelines
Primary implant of a PLATINIUM 4LV CRTD or upgrade from an existing ICD connected to a RV lead with a DF4 connector (DF4LLHH) to a PLATINIUM 4LV CRT-D
Signed and dated informed consent

Exclusion criteria

Patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (DSP) eluted from the NAVIGO 4LV lead maybe contraindicated
Venous anomalies precluding transvenous implant (contraindication of a Pacemaker or ICD implant)
Active myocarditis, pocket and/or lead infection
Stroke/myocardiaI infarction one month prior to implant
Already included in another clinical study that could confound the results of this study.
Inability to meet Follow-up visits at the implanting centre as defined in the investigational plan.
Patient less than 18 years old or under guardianship
Known pregnancy, women in lactation period or in childbearing age without an adequate contraceptive method (failure rate < 1%)
Drug addiction or abuse