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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arrythmia, Implatable Cardioverter Defibrillation, Lead

Intervention / Treatment
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* Device: NAVIGO 4LV lead implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: NAVIGO 4LV LV leads are available as S shaped(NAVIGO 4LV 2D) , U shaped (NAVIGO 4LV ARC) and straight( NAVIGO 4LV Pilot) models. All the models are available in 78 cm and 88 cm long versions. All models are designed for multipolar pacing (4 electrodes) and all of them have a quadripolar IS4 connector (IS4_LLLL). The NAVIGO 4LV leads are steroid eluting to avoid adverse effects due to inflammation reaction of the myocardium after positioning of the lead, and therefore to limit the acute pacing threshold peak. The steroid collar design is the same as the one used in all other LIVANOVA leads
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVIGO 4LV implant<br>All patients will be attempted to implant or implanted with NAVIGO 4LV lead | Device: NAVIGO 4LV lead implant<br>* All patients will be attempted to implant or implanted with NAVIGO 4LV lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV lead Safety at 10 weeks | Freedom from LV lead-related complications, defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) that occurred within 30 days after successful implant of the CRT-D system | 10 weeks after implant | 
| LV lead Performance at 10 weeks | Successful performance defined as LV pacing threshold at 10 weeks < 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude | 10 weeks after implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical performance | LV pacing threshold amplitude (V) and LV pacing impedance (Ohm) | through study completion, an average of 6 month | 
| Rate of patients free from LV lead-related complications | Freedom from LV lead-related complications defined as any investigational device deficiency or any serious adverse device event (SADE) that resulted in patient death or required a re-intervention (not including re-programming) | through study completion, an average of 6 month | 
| LV lead-related SAEs | Serious Adverse Event LV related | through study completion, an average of 6 month | 
| Lead handing assessment of NAVIGO 4LV leads through a questionnaire | A questionnaire on lead handling will track opinion from the investigator, comparing his assessment with this lead to device he is accustomed to implant | Implant | 
| NAVIGO 4LV lead implant success rate on enrolled population | To report the NAVIGO 4LV lead implant success rate | Enrollment | 
| Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation | To report the number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation | 10 weeks | 
| Number of patients with MP pacing activated | To report the number of patients with MP pacing activated | through study completion, an average of 6 month | 
| Rationale to activate MP | To report the reason why physician decide to activate MP to the patient | through study completion, an average of 6 month | 
| Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude | To report the number of patients with at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude | through study completion, an average of 6 month | 
| Number of patients at each final programmed pacing vector and changes | To report number of patients at each final programmed pacing vector and changes | through study completion, an average of 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety , electrical performance