Status:
UNKNOWN
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Lead Sponsor:
MicroPort CRM
Conditions:
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 Str...
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 ventricul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
317 Patients enrolled
Trial Details
Trial ID
NCT03279484
Start Date
November 24 2017
End Date
March 1 2022
Last Update
September 17 2019
Active Locations (38)
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1
CHRU Brest
Brest, France, 29609
2
CHRU Hopital Trousseau
Chambray-lès-Tours, France, 37170
3
CH Robert Boulin
Libourne, France, 33505
4
CHU Hôpital Nord - Marseille
Marseille, France, 13020