Bradycardia, Left Bundle Branch Area Pacing, Left Bundle Branch Pacing
Conditions
Brief summary
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.
Interventions
DEVICEUse of LINEA cardiac pacing lead
Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(phase I and II): * Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC) * Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM * Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area * Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated
Exclusion criteria
(phase I and II): * Patient planned for a device upgrade, or a device or a lead replacement * Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy * Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35% * Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device) * Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery) * Patient with a life expectancy of less than 2 years * Minor age patient (i.e. under 18 years of age) * Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation * Non-menopausal women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LINEA lead complication free rate at 3 months | 3 months after implantation | 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 |
| LINEA lead pacing threshold amplitude at 3 months | 3 months after implantation | Mean ventricular pacing threshold amplitude |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of LINEA lead minimum sensed amplitude | 3 months after implantation | Proportion of patients with minimum sensed amplitude ≥ 5 mV |
| General performances of LINEA lead | Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation | 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 |
| Safety of the LINEA lead | Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation | LINEA lead complication free rate over time, calculated based on number of Adverse Events and Device Deficiencies related to the lead |
| Safety of the FLEXIGO delivery catheter and the FLEXIGO slitter | Implantation, 72 hours from implantation, 1 month, 3 months, 6 months, 18 months, 30 months and 42 months after implantation | FLEXIGO catheter complication free rate, calculated based on number of Adverse Events and Device Deficiencies related to the catheter or the slitter |
| LINEA lead implantation success rates | Implantation | Proportion of LINEA leads implanted in the interventricular septum and meeting or not LBBAP criteria |
| Lead and delivery catheter implantation time | Implantation | Total procedural time and total fluoroscopic time of each implantation |
| LINEA lead and FLEXIGO delivery catheter and slitter implantation usability | Implantation | Handling scores based on a specific questionnaire (scale Very poor/Poor/Acceptable/Good/Very good) |
| Right Ventricular Autothreshold performances | 3 months after implantation | \- 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 |
| Evolution of LBBAP capture over time | 18 months after implantation | \- LBBAP capture evolution with analyses of ECGs (i.e. V6 R-wave peak time and V6-V1 interpeak interval) and LBBAP criteria collected |
Contacts
CONTACTAntoine Guihard
Outcome results
None listed