Health TrialsbyHealthPanel

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

ConditionsBradycardiaLeft Bundle Branch Area PacingCardiac Resynchronisation Therapy (CRT)ECG
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicroPort CRM

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Incapacitated subject or under guardianship

inability to understand the purpose of the study

Minor subjects

Non menopausal women

Trial design

Design model

Single group

Treatments tested in this trial

  • LBBAP implant

    Device

    Use of Smart ECG system during the LBB implant

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: Use of Smart ECG system in subject with indication for LBBAPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline/ procedure

Secondary outcomes

1

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.

Time frame
baseline/ procedure
2

Identification of LBB transitions

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)

Time frame
baseline/ procedure
3

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

Time frame
baseline/ procedure
4

Signal quality analysis

Comparison of Smart ECG versus EP signal quality analysis (signal to noise ratio, frequency analyses)

Time frame
baseline/ procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MicroPort CRM

Lead sponsor

Source ClinicalTrials.gov
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