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MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation

NCT03340922 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-10-20

No results posted yet for this study

Summary

Current navigation systems incorporate algorithms for automatic identification of local activation time (LAT). However, data about their utility and accuracy in premature ventricular complex (PVC) ablation procedures are scarce. This prospective, randomized study analyzes the accuracy and effectivity of an algorithmic method based on automatic annotation of the maximal negative slope of the unipolar electrogram within the window demarcated by the bipolar electrogram, compared with conventional, manual annotation during PVC ablation procedures.

Conditions

  • Ventricular Premature Complexes
  • Catheter Ablation

Interventions

DEVICE

Automatic annotation of LAT (WF-method)

Automatic annotation of LAT during PVC activation mapping. Acquisition of points will be automatically performed using the Wavefront (WF) annotation tool integrated into CARTO navigation system.

DEVICE

Manual annotation of LAT (M-method)

Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.

Sponsors & Collaborators

  • Centro Medico Teknon

    lead OTHER

Principal Investigators

  • Antonio Berruezo, MD, PhD · Centro Medico Teknon

  • Felipe Bisbal, MD, PhD · Hospital Universitari German Trias i Pujol (Badalona, Spain)

  • Alonso Pedrote, MD, PhD · Virgen del Rocio University Hospital (Sevilla, Spain)

  • Diego Penela, MD, PhD · Ospedale Guglielmo da Saliceto (Piacenza, Italy)

  • Juan Fernández-Armenta, MD, PhD · Puerta del Mar University Hospital (Cadiz, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03340922 on ClinicalTrials.gov