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Clinical Trials/NCT06509763
NCT06509763
Completed
Not Applicable

ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria

Hospital Clinic of Barcelona1 site in 1 country50 target enrollmentSeptember 29, 2022

Overview

Phase
Not Applicable
Intervention
ECGI system during LBBP implant
Conditions
Cardiac Resynchronization Therapy
Sponsor
Hospital Clinic of Barcelona
Enrollment
50
Locations
1
Primary Endpoint
Left ventricular resynchronization assessed by ECGI
Status
Completed
Last Updated
29 days ago

Overview

Brief Summary

The goal is to validate the resynchronization criteria with a non-invasive technique, during the LBBP implant. Non-invasive real-time ventricular activation maps will be created and analyzed before, during, and after the implantation of the left bundle branch lead, including right septal pacing, mid and deep septal pacing and pacing when reaching the left bundle branch according to the published standard LBBP criteria. Using these maps, the investigators will quantify activation times and evaluate changes in the ventricular sequence during implantation.

Registry
clinicaltrials.gov
Start Date
September 29, 2022
End Date
November 15, 2025
Last Updated
29 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Josep Lluis Mont Girbau

Arrhythmia Section MD PhD

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

  • Left bundle branch pacing indication
  • Capability of standing up to place the ECGI vest

Exclusion Criteria

  • Less than 18 years-old
  • Patients with cognitive impairment

Arms & Interventions

Left Bundle Branch electrode implant

Intervention: ECGI system during LBBP implant

Outcomes

Primary Outcomes

Left ventricular resynchronization assessed by ECGI

Time Frame: During procedure

Resynchronization assesed by non-invasive ECGI by the Left Ventricle Activation Time reduction and the septal activation ventricular pattern once reaching the LBBP according to the published ECG criteria.

Secondary Outcomes

  • LVDI(During procedure)
  • VEU(During procedure)
  • LVAT(During procedure)
  • Isochronal Crowding(During procedure)
  • Histogram Overlap(During procedure)

Study Sites (1)

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