Bradycardia, Cardiac Resynchronisation Therapy (CRT), ECG, Left Bundle Branch Area Pacing
Conditions
Keywords
LBBAP ECG MONITORING ASSISTANT
Brief summary
To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area
Detailed description
The clinical investigation aims to support physicians with a portable and easy to use solution to display ECG and to provide automatic calculation of key ECG indicators (Left Ventricular Activation time (LVAT) and V6-V1 interval) for LBB implantation procedure. This allows physicians to concentrate on lead placement with the benefice from immediate ECG measurements thanks to the automatic software. The Smart ECG system is class IIA device and it is composed of: 1. CE-marked Smart ECG, Class IIa medical device (rule 10 Annex VIII of MDR) 2. ECG viewer Software (HookUp SmarV2) (providing 12 lead ECG display + automatic interval measurements + shadow plot for QRS visualization) Class IIa medical device (rule 11 Annex VIII of MDR). 3. CE -marked 12 leads ECG cables radiotransparent and defibrillation proof (Class I device) 4. Commercial PC used in combination with the devices under evaluation The study is a pre-market, non-pivotal study: HookUp Smart V2 software is a non-implantable Class IIA device, with no interaction with the human body and the demonstration of conformity with general safety and performance requirements is based on the results of non-clinical testing methods alone (as article 61(10) from MDR.
Interventions
DEVICELBBAP implant
Use of Smart ECG system during the LBB implant
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT) * Subject signed and dated the ICF
Exclusion criteria
* Incapacitated subject or under guardianship * inability to understand the purpose of the study * Minor subjects * Non menopausal women * Patients implanted with other electrically active non cardiac devices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Capability to monitor LBB success criteria with the use of Smart ECG system | baseline/ procedure | Proportion of investigators providing an overall favorable assessment (assessed GOOD or ACCEPTABLE) on a four- point scale (GOOD, ACCEPTABLE, POOR, VERY POOR) on the use of Smart ECG system to achieve LBB area pacing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy of the two measurements (LVAT and V6-V1) | baseline/ procedure | The accuracy of the two measurements (LVAT and V6-V1) during the final LBB lead position (LBBAP) will be assessed separately by comparing manual and automatic methods. |
| Identification of LBB transitions | baseline/ procedure | Concordance between EP and Smart ECG for the identification of LBB transitions (non-selective to selective or non-selective to LVSP, during threshold test at final lead position) |
| Type of LBB capture | baseline/ procedure | Concordance of type of LBB capture as determined by EP vs Smart ECG signals (LBBAP, likely LBBAP, LVSP) - based on centralized blinded review of EP annotated screenshot and Smart ECG recordings |
| Signal quality analysis | baseline/ procedure | Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses) |
| Investigator's satisfaction | baseline/ procedure | Investigator's satisfaction questionnaire about using Smart ECG system during the full procedure (i.e .setting the system for the procedure, monitoring lead progression, assessing pacing capture) |
| Safety reporting | baseline/ procedure | To report any SADE, ADE, DD occurred during the investigational procedure |
Countries
France
Contacts
Primary ContactMaria Martino, Project Manager
Outcome results
None listed