Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution (LBBOT)

MicroPort

Status: Enrolling

Conditions: Bradycardia; ECG; Left Bundle Branch Area Pacing; Cardiac Resynchronisation Therapy (CRT)

Treatments: Device: LBBAP implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07254013

WSEN01

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Use of Smart ECG system in subject with indication for LBBAP

Experimental group

Description:

Smart ECG system will be used in addition to EP system in subjects with indication for LBBAP

Treatment:

Device: LBBAP implant