The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
LINEA lead complication free rate at 3 months
Proportion of patients free from complication related to the LINEA lead. A complication is defined as a SADE with a probable or causal relationship to the LINEA lead which triggered an additional invasive intervention or resulted in patient death
Time frame: 3 months after implantation
LINEA lead pacing threshold amplitude at 3 months
Mean ventricular pacing threshold amplitude
Time frame: 3 months after implantation
Success rate of LINEA lead minimum sensed amplitude
Proportion of patients with minimum sensed amplitude ≥ 5 mV
Time frame: 3 months after implantation
General performances of LINEA lead
Pacing threshold amplitude, impedance and minimum sensed amplitude obtained with the LINEA lead at each patient's visit. LBB pacing threshold amplitude obtained with the LINEA lead during implantation, as well as the chronaxie measurement
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the LINEA lead
LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the lead
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter
FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the slitter
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation
LINEA lead implantation success rates
Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria
Time frame: Implantation
Lead and delivery catheter implantation time
Total procedural time and total fluoroscopic time of each implantation
Time frame: Implantation
LINEA lead and FLEXIGO delivery catheter and slitter implantation usability
Handling scores based on a specific questionnaire (scale Very poor/Poor/Acceptable/Good/Very good)
Time frame: Implantation
Right Ventricular Autothreshold performances
\- Accuracy - Comparison between the manual ventricular pacing threshold performed by a physician and the in-clinic ventricular pacing threshold provided by the RVAT function at the same pulse width and during the same on-site patient's visit
Time frame: 3 months after implantation
Evolution of LBBAP capture over time
\- LBBAP capture evolution with analyses of ECGs (i.e. V6 R-wave peak time and V6-V1 interpeak interval) and LBBAP criteria collected
Time frame: 18 months after implantation