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

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

Study Overview

• Status: Unknown
• Conditions: Arrythmia, Implatable Cardioverter Defibrillation, Lead
• Intervention / Treatment: Device: NAVIGO 4LV lead implant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU Brest
  • Chambray-lès-Tours, France, 37170
    • CHRU Hopital Trousseau
  • Libourne, France, 33505
    • CH Robert Boulin
  • Marseille, France, 13020
    • CHU Hôpital Nord - Marseille
  • Massy, France, 91349
    • Institut Hospitalier Jacques Cartier
  • Metz-Tessy, France, 74374
    • CH Annecy Genevois
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75014
    • Groupe Hospitalier Paris St Joseph
  • Pessac, France, 33600
    • CHU Bordeaux
  • Rouen, France, 76031
    • CHU Hôpital Charles Nicolle
  • Toulouse, France, 31059
    • CHU Rangueil
  • Valence, France, 26953
    • Centre Hospitalier de Valence
  • Vandoeuvre les Nancy, France, 54500
    • CHRU Brabois
• Germany
  • Bad Bevensen, Germany, 29594
    • Herz- und Gefässzentrum Bad Bevensen
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Bielefeld, Germany, 33617
    • Evangelisches Krankenhaus
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Darmstadt, Germany, 64287
    • Kardiologie Darmstadt
  • Freiburg, Germany, 79106
    • Universitats-Herzzentrum Freiburg
  • Hamburg, Germany, 22457
    • Albertinen-Krankenhau
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Wurzburg, Germany, 97080
    • Universitätsklinikum
• Italy
  • Ancona, Italy, 60126
    • Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
  • Pisa, Italy, 56126
    • Ospedale Universitario Di Pisa
  • Udine, Italy, 33100
    • Az. Osp. Univ. S. Maria della Misericordia
• Netherlands
  • Zwolle, Netherlands, 10500
    • Isala Klinieken
• Portugal
  • Carnaxide, Portugal, 2799
    • Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
  • Coimbra, Portugal, 3041-801
    • Centro Hospitalar e Universitario de Coimbra - Hospital Geral
  • Lisboa, Portugal, 1649-035
    • Centro H. Lisboa Norte - Hospital de Santa Maria
  • Lisbon, Portugal, 1169-024
    • CHCL - Hospital Santa Marta
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto CHP Hospital de Santo Antonio
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañon
  • Oviedo, Spain, 33011
    • H. Universitario Central de Asturias
  • Valencia, Spain, 46009
    • Hospital Universitario La Fé
  • Vigo, Spain, 36312
    • Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAVIGO 4LV implant; All patients will be attempted to implant or implanted with NAVIGO 4LV lead	Device: NAVIGO 4LV lead implant; All patients will be attempted to implant or implanted with NAVIGO 4LV lead

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MicroPort CRM
• Investigators: Principal Investigator: Juan Gabriel Martinez Martinez, Hospital General Universitario Alicante Spain

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: safety , electrical performance
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: LCPL01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No