Clinical trial NCT03279484: Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Official title: Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrythmia, Implatable Cardioverter Defibrillation, Lead
Keywords: safety , electrical performance
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: LV lead Safety at 10 weeks
timeFrame: 10 weeks after implant
measure: LV lead Performance at 10 weeks
timeFrame: 10 weeks after implant
Secondary outcomes:
measure: Electrical performance
timeFrame: through study completion, an average of 6 month
measure: Rate of patients free from LV lead-related complications
timeFrame: through study completion, an average of 6 month
measure: LV lead-related SAEs
timeFrame: through study completion, an average of 6 month
measure: Lead handing assessment of NAVIGO 4LV leads through a questionnaire
timeFrame: Implant
measure: NAVIGO 4LV lead implant success rate on enrolled population
timeFrame: Enrollment
measure: Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation
timeFrame: 10 weeks
measure: Number of patients with MP pacing activated
timeFrame: through study completion, an average of 6 month
measure: Rationale to activate MP
timeFrame: through study completion, an average of 6 month
measure: Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude
timeFrame: through study completion, an average of 6 month
measure: Number of patients at each final programmed pacing vector and changes
timeFrame: through study completion, an average of 6 month
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
city: Chambray-lès-Tours
country: France
facility: CHRU Hopital Trousseau
city: Libourne
country: France
facility: CH Robert Boulin
city: Marseille
country: France
facility: CHU Hôpital Nord - Marseille
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Metz-Tessy
country: France
facility: CH Annecy Genevois
city: Paris
country: France
facility: Groupe Hospitalier Paris St Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: CHU Bordeaux
city: Rouen
country: France
facility: CHU Hopital Charles Nicolle
city: Toulouse
country: France
facility: CHU Rangueil
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Vandoeuvre les Nancy
country: France
facility: CHRU Brabois
city: Bad Bevensen
country: Germany
facility: Herz- und Gefässzentrum Bad Bevensen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Darmstadt
country: Germany
facility: Kardiologie Darmstadt
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg
city: Hamburg
country: Germany
facility: Albertinen-Krankenhau
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Wurzburg
country: Germany
facility: Universitatsklinikum
city: Ancona
country: Italy
facility: Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
city: Pisa
country: Italy
facility: Ospedale Universitario Di Pisa
city: Udine
country: Italy
facility: Az. Osp. Univ. S. Maria della Misericordia
city: Zwolle
country: Netherlands
facility: ISALA Klinieken
city: Carnaxide
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
city: Coimbra
country: Portugal
facility: Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra - Hospital Geral
city: Lisboa
country: Portugal
facility: Centro H. Lisboa Norte - Hospital de Santa Maria
city: Lisbon
country: Portugal
facility: CHCL - Hospital Santa Marta
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto CHP Hospital de Santo Antonio
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Oviedo
country: Spain
facility: H. Universitario Central de Asturias
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Study officials:
affiliation: Hospital General Universitario Alicante Spain
name: Juan Gabriel Martinez Martinez
role: PRINCIPAL_INVESTIGATOR
References: