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
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
317
All patients will be attempted to implant or implanted with NAVIGO 4LV lead
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
Time frame: 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
Time frame: 10 weeks after implant
Electrical performance
LV pacing threshold amplitude (V) and LV pacing impedance (Ohm)
Time frame: 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)
Time frame: through study completion, an average of 6 month
LV lead-related SAEs
Serious Adverse Event LV related
Time frame: 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
Time frame: Implant
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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
...and 28 more locations
NAVIGO 4LV lead implant success rate on enrolled population
To report the NAVIGO 4LV lead implant success rate
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
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
Number of patients with MP pacing activated
To report the number of patients with MP pacing activated
Time frame: 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
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
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
Number of patients at each final programmed pacing vector and changes
To report number of patients at each final programmed pacing vector and changes
Time frame: through study completion, an average of 6 month