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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LINEA cardiac pacing lead | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of LINEA cardiac pacing lead | Device | Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after implantation |
| LINEA lead pacing threshold amplitude at 3 months | Mean ventricular pacing threshold amplitude | 3 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of LINEA lead minimum sensed amplitude | Proportion of patients with minimum sensed amplitude ≥ 5 mV | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Early outcome - Absence of Unanticipated Serious Adverse Device Effect (USADE) related to LINEA lead | Proportion of patients free from USADE. Any event caused by use of the LINEA lead or any accessory packaged with the lead, will be considered as an ADE related to the LINEA lead. The endpoint evaluation will be based on an independent safety events adjudication from a Clinical Events Committee (CEC), based on investigational site reporting |
Inclusion criteria (phase I and II):
Exclusion criteria (phase I and II):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Guihard | Contact | +33 1 46 01 33 20 | antoine.guihard@crm.microport.com |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 | 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 | 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 | Implantation |
| Lead and delivery catheter implantation time | Total procedural time and total fluoroscopic time of each implantation | 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) | 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 | 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 | 18 months after implantation |
| 1 month after implantation |
| Early outcome - LINEA lead pacing threshold amplitude at 1 month | Mean ventricular pacing threshold amplitude | 1 month after implantation |
| Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance | - Implantation success rate - Proportion of LINEA lead successfully implanted at the interventricular septum and fulfilling or not LBBAP success criteria according to the operator's decision | 1 month after implantation |
| Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance | - Short term electrical performances variation - Pacing threshold variation between implantation and 1 month, and electrical performances of the LINEA lead (pacing threshold, impedance and minimum sensed amplitude) | 1 month after implantation |
| Early outcome - Other LINEA lead and FLEXIGO delivery catheter safety and performance | - Complication free rate - 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 | 1 month after implantation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |