Back to resultsSafety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector (NAVIGATOR)
Primary Purpose
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NAVIGO 4LV lead implant
Sponsored by
About this trial
This is an interventional treatment trial for Arrythmia, Implatable Cardioverter Defibrillation, Lead focused on measuring safety , electrical performance
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
Sites / Locations
- CHRU Brest
- CHRU Hopital Trousseau
- CH Robert Boulin
- CHU Hôpital Nord - Marseille
- Institut Hospitalier Jacques Cartier
- CH Annecy Genevois
- Groupe Hospitalier Paris St Joseph
- Institut Mutualiste Montsouris
- CHU Bordeaux
- CHU Hopital Charles Nicolle
- CHU Rangueil
- Centre Hospitalier de Valence
- CHRU Brabois
- Herz- und Gefässzentrum Bad Bevensen
- Herz- und Diabeteszentrum
- Deutsches Herzzentrum Berlin
- Evangelisches Krankenhaus
- Klinikum Coburg
- Kardiologie Darmstadt
- Universitäts-Herzzentrum Freiburg
- Albertinen-Krankenhau
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
- Universitatsklinikum
- Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
- Ospedale Universitario Di Pisa
- Az. Osp. Univ. S. Maria della Misericordia
- ISALA Klinieken
- Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
- Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
- Centro Hospitalar e Universitário de Coimbra - Hospital Geral
- Centro H. Lisboa Norte - Hospital de Santa Maria
- CHCL - Hospital Santa Marta
- Centro Hospitalar do Porto CHP Hospital de Santo Antonio
- Hospital General Universitario de Alicante
- Hospital Universitario Gregorio Marañón
- H. Universitario Central de Asturias
- Hospital Universitario La Fe
- Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NAVIGO 4LV implant
Arm Description
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Electrical performance
LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
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)
LV lead-related SAEs
Serious Adverse Event LV related
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
NAVIGO 4LV lead implant success rate on enrolled population
To report the NAVIGO 4LV lead implant success rate
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
Number of patients with MP pacing activated
To report the number of patients with MP pacing activated
Rationale to activate MP
To report the reason why physician decide to activate MP to the patient
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
Number of patients at each final programmed pacing vector and changes
To report number of patients at each final programmed pacing vector and changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03279484
Brief Title
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Acronym
NAVIGATOR
Official Title
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Implatable Cardioverter Defibrillation, Lead
Keywords
safety , electrical performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
317 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAVIGO 4LV implant
Arm Type
Experimental
Arm Description
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Intervention Type
Device
Intervention Name(s)
NAVIGO 4LV lead implant
Intervention Description
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Primary Outcome Measure Information:
Title
LV lead Safety at 10 weeks
Description
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
Time Frame
10 weeks after implant
Title
LV lead Performance at 10 weeks
Description
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
Time Frame
10 weeks after implant
Secondary Outcome Measure Information:
Title
Electrical performance
Description
LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
Time Frame
through study completion, an average of 6 month
Title
Rate of patients free from LV lead-related complications
Description
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)
Time Frame
through study completion, an average of 6 month
Title
LV lead-related SAEs
Description
Serious Adverse Event LV related
Time Frame
through study completion, an average of 6 month
Title
Lead handing assessment of NAVIGO 4LV leads through a questionnaire
Description
A questionnaire on lead handling will track opinion from the investigator, comparing his assessment with this lead to device he is accustomed to implant
Time Frame
Implant
Title
NAVIGO 4LV lead implant success rate on enrolled population
Description
To report the NAVIGO 4LV lead implant success rate
Time Frame
Enrollment
Title
Number of patients with at least 2 pacing vectors with pacing threshold < 2.5 V at 0.5 ms and no phrenic nerve stimulation
Description
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
Time Frame
10 weeks
Title
Number of patients with MP pacing activated
Description
To report the number of patients with MP pacing activated
Time Frame
through study completion, an average of 6 month
Title
Rationale to activate MP
Description
To report the reason why physician decide to activate MP to the patient
Time Frame
through study completion, an average of 6 month
Title
Number of patients with of at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude
Description
To report the number of patients with at least one MP configuration with no phrenic nerve stimulation at programmed pacing amplitude
Time Frame
through study completion, an average of 6 month
Title
Number of patients at each final programmed pacing vector and changes
Description
To report number of patients at each final programmed pacing vector and changes
Time Frame
through study completion, an average of 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Gabriel Martinez Martinez
Organizational Affiliation
Hospital General Universitario Alicante Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHRU Hopital Trousseau
City
Chambray-lès-Tours
ZIP/Postal Code
37170
Country
France
Facility Name
CH Robert Boulin
City
Libourne
ZIP/Postal Code
33505
Country
France
Facility Name
CHU Hôpital Nord - Marseille
City
Marseille
ZIP/Postal Code
13020
Country
France
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
ZIP/Postal Code
91349
Country
France
Facility Name
CH Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74374
Country
France
Facility Name
Groupe Hospitalier Paris St Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CHU Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
CHRU Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Herz- und Gefässzentrum Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29594
Country
Germany
Facility Name
Herz- und Diabeteszentrum
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Kardiologie Darmstadt
City
Darmstadt
ZIP/Postal Code
64287
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Albertinen-Krankenhau
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedale Universitario Di Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Az. Osp. Univ. S. Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
ISALA Klinieken
City
Zwolle
ZIP/Postal Code
10500
Country
Netherlands
Facility Name
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
City
Carnaxide
ZIP/Postal Code
2799
Country
Portugal
Facility Name
Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar e Universitário de Coimbra - Hospital Geral
City
Coimbra
ZIP/Postal Code
3041-801
Country
Portugal
Facility Name
Centro H. Lisboa Norte - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
CHCL - Hospital Santa Marta
City
Lisbon
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H. Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
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