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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Smart ECG system in subject with indication for LBBAP | Experimental | Smart ECG system will be used in addition to EP system in subjects with indication for LBBAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP implant | Device | Use of Smart ECG system during the LBB implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Capability to monitor LBB success criteria with the use of Smart ECG system | 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. | baseline/ procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of the two measurements (LVAT and V6-V1) | 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. | baseline/ procedure |
| Identification of LBB transitions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Martino, Project Manager | Contact | +393351005007 | maria.martino@crm.microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Pierre- Antoine Catalan | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Not yet recruiting | Besançon | France | 25030 | France |
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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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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) |
| baseline/ procedure |
| Type of LBB capture | 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 | baseline/ procedure |
| Signal quality analysis | Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses) | baseline/ procedure |
| Investigator's satisfaction | 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) | baseline/ procedure |
| Safety reporting | To report any SADE, ADE, DD occurred during the investigational procedure | baseline/ procedure |
| Clermont Ferrand | Recruiting | Clermont-Ferrand | France | 63003 | France |
|
| CHU Grenoble Alpes | Not yet recruiting | Grenoble | France | 38043 | France |
|
| Clinique du Millénaire | Recruiting | Montpellier | France | 34000 | France |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |