Arrythmia, Implatable Cardioverter Defibrillation, Lead
Conditions
Keywords
safety , electrical performance
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.
Interventions
DEVICENAVIGO 4LV lead implant
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LV lead Safety at 10 weeks | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LV lead-related SAEs | through study completion, an average of 6 month | Serious Adverse Event LV related |
| Lead handing assessment of NAVIGO 4LV leads through a questionnaire | 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 | 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 | 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 |
| Electrical performance | through study completion, an average of 6 month | LV pacing threshold amplitude (V) and LV pacing impedance (Ohm) |
| Rationale to activate MP | 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 | 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 | through study completion, an average of 6 month | To report number of patients at each final programmed pacing vector and changes |
| Number of patients with MP pacing activated | through study completion, an average of 6 month | To report the number of patients with MP pacing activated |
| Rate of patients free from LV lead-related complications | 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) |
Countries
France, Germany, Italy, Netherlands, Portugal, Spain
Outcome results
None listed