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ElectrocardioGraphic Imaging During Left bUndle Branch Implant to valiDate Ecg Criteria (GUIDE)

H

Hospital Clinic of Barcelona

Status

Active, not recruiting

Conditions

Cardiac Resynchronization Therapy

Treatments

Device: ECGI system during LBBP implant

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Left Bundle Branch electrode implant
Experimental group
Treatment:
Device: ECGI system during LBBP implant

Trial contacts and locations

1

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Central trial contact

Mariona Regany, MSc; Jose M Tolosana, MD, PhD

Data sourced from clinicaltrials.gov

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