Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector
- Conditions
- Arrythmia, Implatable Cardioverter Defibrillation, Lead
- Registration Number
- NCT03279484
- Lead Sponsor
- MicroPort CRM
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 317
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Electrical performance 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 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)
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
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
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
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
Trial Locations
- Locations (38)
CHRU Brest
🇫🇷Brest, France
CHRU Hopital Trousseau
🇫🇷Chambray-lès-Tours, France
CH Robert Boulin
🇫🇷Libourne, France
CHU Hôpital Nord - Marseille
🇫🇷Marseille, France
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
CH Annecy Genevois
🇫🇷Metz-Tessy, France
Groupe Hospitalier Paris St Joseph
🇫🇷Paris, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
CHU Bordeaux
🇫🇷Pessac, France
CHU Hopital Charles Nicolle
🇫🇷Rouen, France
Scroll for more (28 remaining)CHRU Brest🇫🇷Brest, France