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

NCT03279484 | Unknown

• 1 other identifier: LCPL01
• Study Type: interventional
• Target: 317
• Locations: 6 countries
• Sites: 38

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

Conditions

Arrythmia, Implatable Cardioverter Defibrillation, Lead

Keywords

safety , electrical performance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Electrical performance

  through study completion, an average of 6 month

• Rate of patients free from LV lead-related complications

  through study completion, an average of 6 month

• LV lead-related SAEs

  through study completion, an average of 6 month

• Lead handing assessment of NAVIGO 4LV leads through a questionnaire

  Implant

• NAVIGO 4LV lead implant success rate on enrolled population

  Enrollment

Study Arms (1)

NAVIGO 4LV implant

EXPERIMENTAL

All patients will be attempted to implant or implanted with NAVIGO 4LV lead

Device: NAVIGO 4LV lead implant

Interventions

NAVIGO 4LV lead implant DEVICE

All patients will be attempted to implant or implanted with NAVIGO 4LV lead

NAVIGO 4LV implant

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (38)

CHRU Brest

Brest, 29609, France

Location

CHRU Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

CH Robert Boulin

Libourne, 33505, France

Location

CHU Hôpital Nord - Marseille

Marseille, 13020, France

Location

Institut Hospitalier Jacques Cartier

Massy, 91349, France

Location

CH Annecy Genevois

Metz-Tessy, 74374, France

Location

Groupe Hospitalier Paris St Joseph

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Bordeaux

Pessac, 33600, France

Location

CHU Hopital Charles Nicolle

Rouen, 76031, France

Location

CHU Rangueil

Toulouse, 31059, France

Location

Centre Hospitalier de Valence

Valence, 26953, France

Location

CHRU Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Herz- und Gefässzentrum Bad Bevensen

Bad Bevensen, 29594, Germany

Location

Herz- und Diabeteszentrum

Bad Oeynhausen, 32545, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

Evangelisches Krankenhaus

Bielefeld, 33617, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Kardiologie Darmstadt

Darmstadt, 64287, Germany

Location

Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Albertinen-Krankenhau

Hamburg, 22457, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitatsklinikum

Würzburg, 97080, Germany

Location

Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

Ancona, 60126, Italy

Location

Ospedale Universitario Di Pisa

Pisa, 56126, Italy

Location

Az. Osp. Univ. S. Maria della Misericordia

Udine, 33100, Italy

Location

ISALA Klinieken

Zwolle, 10500, Netherlands

Location

Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

Carnaxide, 2799, Portugal

Location

Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar e Universitário de Coimbra - Hospital Geral

Coimbra, 3041-801, Portugal

Location

CHCL - Hospital Santa Marta

Lisbon, 1169-024, Portugal

Location

Centro H. Lisboa Norte - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar do Porto CHP Hospital de Santo Antonio

Porto, 4099-001, Portugal

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

H. Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

Vigo, 36312, Spain

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Gabriel Martinez Martinez

  Hospital General Universitario Alicante Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 12, 2017
• Study Start: November 24, 2017
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2022
• Last Updated: September 17, 2019

Record last verified: 2019-01

Locations

PT (6); DE (10); ES (5); FR (13); IT (3); NL (1)