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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-14

Study Completion Date

2026-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Use of Smart ECG system in subject with indication for LBBAP

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

Group Type EXPERIMENTAL

LBBAP implant

Intervention Type DEVICE

Use of Smart ECG system during the LBB implant

Interventions

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LBBAP implant

Use of Smart ECG system during the LBB implant

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes