Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
NCT ID: NCT03279484
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
317 participants
INTERVENTIONAL
2017-11-24
2022-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
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
TREATMENT
NONE
Study Groups
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NAVIGO 4LV implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
NAVIGO 4LV lead implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Interventions
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NAVIGO 4LV lead implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Juan Gabriel Martinez Martinez
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Alicante Spain
Locations
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CHRU Brest
Brest, , France
CHRU Hopital Trousseau
Chambray-lès-Tours, , France
CH Robert Boulin
Libourne, , France
CHU Hôpital Nord - Marseille
Marseille, , France
Institut Hospitalier Jacques Cartier
Massy, , France
CH Annecy Genevois
Metz-Tessy, , France
Groupe Hospitalier Paris St Joseph
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
CHU Bordeaux
Pessac, , France
CHU Hopital Charles Nicolle
Rouen, , France
CHU Rangueil
Toulouse, , France
Centre Hospitalier de Valence
Valence, , France
CHRU Brabois
Vandœuvre-lès-Nancy, , France
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, , Germany
Herz- und Diabeteszentrum
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Evangelisches Krankenhaus
Bielefeld, , Germany
Klinikum Coburg
Coburg, , Germany
Kardiologie Darmstadt
Darmstadt, , Germany
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, , Germany
Albertinen-Krankenhau
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitatsklinikum
Würzburg, , Germany
Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
Ancona, , Italy
Ospedale Universitario Di Pisa
Pisa, , Italy
Az. Osp. Univ. S. Maria della Misericordia
Udine, , Italy
ISALA Klinieken
Zwolle, , Netherlands
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
Carnaxide, , Portugal
Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
Coimbra, , Portugal
Centro Hospitalar e Universitário de Coimbra - Hospital Geral
Coimbra, , Portugal
CHCL - Hospital Santa Marta
Lisbon, , Portugal
Centro H. Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
Porto, , Portugal
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
H. Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Vigo, , Spain
Countries
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Other Identifiers
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LCPL01
Identifier Type: -
Identifier Source: org_study_id
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