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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279484
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
MicroPort CRM

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE November 24, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • LV lead Safety at 1 month [ Time Frame: 1 month 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 1 month [ Time Frame: 1 month after implant ]
    Successful performance defined as LV pacing threshold at 1 month < 2.5 V/0.5 ms observed on at least one pacing vector and absence of phrenic nerve stimulation at programmed pacing amplitude
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Electrical performance [ Time Frame: through study completion, an average of 6 month ]
    LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
  • Rate of patients free from LV lead-related complications [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    Serious Adverse Event LV related
  • Lead handing assessment of NAVIGO 4LV leads through a questionnaire [ Time Frame: Implant ]
    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 [ Time Frame: Enrollment ]
    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 [ Time Frame: 10 weeks ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    To report the number of patients with MP pacing activated
  • Rationale to activate MP [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    To report number of patients at each final programmed pacing vector and changes
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Electrical performance [ Time Frame: through study completion, an average of 6 month ]
    LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
  • Rate of patients free from LV lead-related complications [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    Serious Adverse Event LV related
  • Lead handing assessment of NAVIGO 4LV leads through a questionnaire [ Time Frame: Implant ]
    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 [ Time Frame: Enrollment ]
    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 [ Time Frame: 1 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    To report the number of patients with MP pacing activated
  • Rationale to activate MP [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    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 [ Time Frame: through study completion, an average of 6 month ]
    To report number of patients at each final programmed pacing vector and changes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
Official Title  ICMJE Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
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

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arrythmia, Implatable Cardioverter Defibrillation, Lead
Intervention  ICMJE Device: NAVIGO 4LV lead implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Study Arms  ICMJE Experimental: NAVIGO 4LV implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Intervention: Device: NAVIGO 4LV lead implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
317
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
262
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Netherlands,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279484
Other Study ID Numbers  ICMJE LCPL01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MicroPort CRM
Study Sponsor  ICMJE MicroPort CRM
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan Gabriel Martinez Martinez Hospital General Universitario Alicante Spain
PRS Account MicroPort CRM
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP