Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LBBAP implant.
- Who it may be relevant to
- Registry conditions: Bradycardia, Left Bundle Branch Area Pacing, Cardiac Resynchronisation Therapy (CRT), ECG. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device LBBAP implant
Use of Smart ECG system during the LBB implant
Primary outcome measures
- Capability to monitor LBB success criteria with the use of Smart ECG system [Time frame: baseline/ procedure]
Secondary outcome measures (6)
- The accuracy of the two measurements (LVAT and V6-V1) [Time frame: baseline/ procedure]
- Identification of LBB transitions [Time frame: baseline/ procedure]
- Type of LBB capture [Time frame: baseline/ procedure]
- Signal quality analysis [Time frame: baseline/ procedure]
- Investigator's satisfaction [Time frame: baseline/ procedure]
- Safety reporting [Time frame: baseline/ procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 4 centers
- CHU de Besançon — Besançon
- Clermont Ferrand — Clermont-Ferrand
- CHU Grenoble Alpes — Grenoble
- Clinique du Millénaire — Montpellier
Identifiers
NCT: NCT07254013 · WSEN01