Arrythmia, Implatable Cardioverter Defibrillation, LeadNAVIGATORNCT03279484
Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
A study testing NAVIGO 4LV lead implant in people with Arrythmia, Implatable Cardioverter Defibrillation, Lead, run by MicroPort CRM at 38 sites in 6 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arrythmia, Implatable Cardioverter Defibrillation, Lead
- What is being tested?
- NAVIGO 4LV lead implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 24 Nov 2017to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
France13 sites
CHRU Brest
Brest, 29609
CHRU Hopital Trousseau
Chambray-lès-Tours, 37170
CH Robert Boulin
Libourne, 33505
CHU Hôpital Nord - Marseille
Marseille, 13020
Institut Hospitalier Jacques Cartier
Massy, 91349
CH Annecy Genevois
Metz-Tessy, 74374
Groupe Hospitalier Paris St Joseph
Paris, 75014
Institut Mutualiste Montsouris
Paris, 75014
CHU Bordeaux
Pessac, 33600
CHU Hopital Charles Nicolle
Rouen, 76031
CHU Rangueil
Toulouse, 31059
Centre Hospitalier de Valence
Valence, 26953
CHRU Brabois
Vandœuvre-lès-Nancy, 54500
Germany10 sites
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, 29594
Herz- und Diabeteszentrum
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Evangelisches Krankenhaus
Bielefeld, 33617
Klinikum Coburg
Coburg, 96450
Kardiologie Darmstadt
Darmstadt, 64287
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, 79106
Albertinen-Krankenhau
Hamburg, 22457
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
Universitatsklinikum
Würzburg, 97080
Portugal6 sites
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
Carnaxide, 2799
Centro Hospitalar Universitário de Coimbra -Hospitais da Universidade de Coimbra
Coimbra, 3000-075
Centro Hospitalar e Universitário de Coimbra - Hospital Geral
Coimbra, 3041-801
CHCL - Hospital Santa Marta
Lisbon, 1169-024
Centro H. Lisboa Norte - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
Porto, 4099-001
Spain5 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario Gregorio Marañón
Madrid, 28007
H. Universitario Central de Asturias
Oviedo, 33011
Hospital Universitario La Fe
Valencia, 46009
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro
Vigo, 36312
Italy3 sites
Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
Ancona, 60126
Ospedale Universitario Di Pisa
Pisa, 56126
Az. Osp. Univ. S. Maria della Misericordia
Udine, 33100
About this study
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
Read the 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.
- Being tested
- NAVIGO 4LV lead implant
- Keywords
- safety , electrical performance
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVIGO 4LV lead implantDevice
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
| Study group | Role | What they receive |
|---|---|---|
| NAVIGO 4LV implant | Experimental | All patients will be attempted to implant or implanted with NAVIGO 4LV lead Receives: Device: NAVIGO 4LV lead implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 weeks after implant
Secondary outcomes (10)
Electrical performance
LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
Measured: 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)
Measured: through study completion, an average of 6 month
LV lead-related SAEs
Serious Adverse Event LV related
Measured: 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
Measured: Implant
NAVIGO 4LV lead implant success rate on enrolled population
To report the NAVIGO 4LV lead implant success rate
Measured: 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
Measured: 10 weeks
Number of patients with MP pacing activated
To report the number of patients with MP pacing activated
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start24 Nov 2017
- Primary completionDec 2019 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrythmia, Implatable Cardioverter Defibrillation, LeadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 317 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Gabriel Martinez Martinez, Principal investigator, Hospital General Universitario Alicante Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279484
- Sponsor's protocol ID
- LCPL01
- Acronym
- NAVIGATOR
- Status last verified
- Jan 2019
- First submitted
- 1 Sep 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez JG, De Sousa J, Dompnier A, Martins-Oliveira M, Israel CW, Teijeira E, Rubin JM, Sebag F, Martino M, Michel Y, Marques P. Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial. Open Heart. 2024 Feb 5;11(1):e002517. doi: 10.1136/openhrt-2023-002517.
PubMed 38316493
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
- ClinicalTrials.gov ID
- NCT03279484
- Acronym / sponsor ID
- NAVIGATOR / LCPL01
- Keywords
- safety , electrical performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| NAVIGO 4LV implant | Experimental | Device: NAVIGO 4LV lead implantAll patients will be attempted to implant or implanted with NAVIGO 4LV lead |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVIGO 4LV lead implantAll patients will be attempted to implant or implanted with NAVIGO 4LV lead | Device | NAVIGO 4LV implant |
Primary outcome
LV lead Safety at 10 weeks
Time frame: 10 weeks after implant
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
Time frame: 10 weeks after implant
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 secondary outcomes
Electrical performance
Time frame: through study completion, an average of 6 month
Rate of patients free from LV lead-related complications
Time frame: through study completion, an average of 6 month
LV lead-related SAEs
Time frame: through study completion, an average of 6 month
Lead handing assessment of NAVIGO 4LV leads through a questionnaire
Time frame: Implant
NAVIGO 4LV lead implant success rate on enrolled population
Time frame: 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
Time frame: 10 weeks
Number of patients with MP pacing activated
Time frame: through study completion, an average of 6 month
Rationale to activate MP
Time frame: 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
Time frame: through study completion, an average of 6 month
Number of patients at each final programmed pacing vector and changes
Time frame: through study completion, an average of 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 38316493Martinez JG, De Sousa J, Dompnier A, Martins-Oliveira M, Israel CW, Teijeira E, Rubin JM, Sebag F, Martino M, Michel Y, Marques P. Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial. Open Heart. 2024 Feb 5;11(1):e002517. doi: 10.1136/openhrt-2023-002517.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Gabriel Martinez Martinez principal investigator
Hospital General Universitario Alicante Spain
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVIGO 4LV lead implant in people with Arrythmia, Implatable Cardioverter Defibrillation, Lead, run by MicroPort CRM at 38 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in France, Germany, Portugal, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV lead Safety at 10 weeks (time frame: 10 weeks after implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.