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

NCT03340922 | Completed Phase 4

• 1 other identifier: Wavefront
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

premature ventricular complex; catheter ablation; activation mapping; wavefront

Outcome Measures

Primary Outcomes (1)

• Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description

  Mapping success will be defined as complete PVC abolition after RF applications at the earliest activation site (EAS) identified using the assigned mapping approach. A maximum of 2 RF applications with appropriate parameters (contact force, impedance drop, catheter stability) during a maximum of 45 seconds will be allowed. If the PVC is not abolished after 2 RF applications with appropriate parameters, mapping will not be considered successful.

  12 months

Secondary Outcomes (8)

• Mapping time

  12 months

• Number of mapped chambers

  12 months

• Accuracy of a proposed algorithm for selection of first chamber to map

  12 months

• Number of target points

  12 months

• Radiofrequency (RF) time

  12 months

Study Arms (2)

Automatic annotation of LAT (WF-method)

EXPERIMENTAL

The annotation of LAT in each acquired point will be automatically performed using the LAT annotation tool integrated into CARTO navigation system, called Wavefront (WF). Automatic annotation of LAT performed by the CARTO system uses the maximum negative slope of the distal U-EGM to set the timing of the mapping annotation, displayed on the corresponding B-EGM. Additionally, the automatic annotation of LAT will be aided by an ECG recognition pattern algorithm (included in the last version of CARTO), which is intended to avoid wrong annotation of ventricular complexes other than the clinical PVC.

Device: Automatic annotation of LAT (WF-method)

Manual annotation of LAT (M-method)

ACTIVE COMPARATOR

A detailed electrocardiogram (ECG)-gated activation map of the chamber of interest will be acquired using the CARTO navigation system. An experienced electrophysiologist will perform the annotation of LAT in each acquired point. The LAT will be measured from the onset of B-EGM (earliest positive or negative deflection) of the distal dipole of the mapping catheter to the defined reference. The use of the U-EGM as a guidance to identify the real onset of B-EGM will be decided under electrophysiologist criteria.

Device: Manual annotation of LAT (M-method)

Interventions

Automatic annotation of LAT (WF-method) DEVICE

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.

Also known as: Wavefront

Automatic annotation of LAT (WF-method)

Manual annotation of LAT (M-method) DEVICE

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

Also known as: Manual

Manual annotation of LAT (M-method)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Indication for PVC ablation.
• Signed informed consent.

You may not qualify if:

• Age \< 18 years.
• Pregnancy.
• PVC ablation procedures guided by pace-mapping (PASO® module); eg. low burden of PVCs during the study, mechanical impact during activation mapping.
• Impossibility to perform activation mapping with the required density of points in the region of interest (see section 4.5.3).
• Concomitant investigation treatments.
• Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Antonio Berruezo, MD, PhD

Barcelona, 08022, Spain

Location

Related Publications (7)

• Stevenson WG, Soejima K. Recording techniques for clinical electrophysiology. J Cardiovasc Electrophysiol. 2005 Sep;16(9):1017-22. doi: 10.1111/j.1540-8167.2005.50155.x.

  PMID: 16174026 BACKGROUND

• Liuba I, Walfridsson H. Activation mapping of focal atrial tachycardia: the impact of the method for estimating activation time. J Interv Card Electrophysiol. 2009 Dec;26(3):169-80. doi: 10.1007/s10840-009-9437-0. Epub 2009 Oct 29.

  PMID: 19866350 BACKGROUND

• Ndrepepa G, Caref EB, Yin H, el-Sherif N, Restivo M. Activation time determination by high-resolution unipolar and bipolar extracellular electrograms in the canine heart. J Cardiovasc Electrophysiol. 1995 Mar;6(3):174-88. doi: 10.1111/j.1540-8167.1995.tb00769.x.

  PMID: 7620643 BACKGROUND

• El Haddad M, Houben R, Stroobandt R, Van Heuverswyn F, Tavernier R, Duytschaever M. Novel algorithmic methods in mapping of atrial and ventricular tachycardia. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):463-72. doi: 10.1161/CIRCEP.113.000833. Epub 2014 May 14.

  PMID: 24829224 BACKGROUND

• Andreu D, Berruezo A, Fernandez-Armenta J, Herczku C, Borras R, Ortiz-Perez JT, Mont L, Brugada J. Displacement of the target ablation site and ventricles during premature ventricular contractions: relevance for radiofrequency catheter ablation. Heart Rhythm. 2012 Jul;9(7):1050-7. doi: 10.1016/j.hrthm.2012.02.018. Epub 2012 Feb 15.

  PMID: 22342861 BACKGROUND

• Penela D, De Riva M, Herczku C, Catto V, Pala S, Fernandez-Armenta J, Acosta J, Cipolletta L, Andreu D, Borras R, Rios J, Mont L, Brugada J, Carbucicchio C, Zeppenfeld K, Berruezo A. An easy-to-use, operator-independent, clinical model to predict the left vs. right ventricular outflow tract origin of ventricular arrhythmias. Europace. 2015 Jul;17(7):1122-8. doi: 10.1093/europace/euu373. Epub 2015 Feb 10.

  PMID: 25672982 BACKGROUND

• Penela D, Van Huls Van Taxis C, Van Huls Vans Taxis C, Aguinaga L, Fernandez-Armenta J, Mont L, Castel MA, Heras M, Tolosana JM, Sitges M, Ordonez A, Brugada J, Zeppenfeld K, Berruezo A. Neurohormonal, structural, and functional recovery pattern after premature ventricular complex ablation is independent of structural heart disease status in patients with depressed left ventricular ejection fraction: a prospective multicenter study. J Am Coll Cardiol. 2013 Sep 24;62(13):1195-202. doi: 10.1016/j.jacc.2013.06.012. Epub 2013 Jul 10.

  PMID: 23850913 BACKGROUND

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Berruezo, MD, PhD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

• Felipe Bisbal, MD, PhD

  Hospital Universitari German Trias i Pujol (Badalona, Spain)

  PRINCIPAL INVESTIGATOR

• Alonso Pedrote, MD, PhD

  Virgen del Rocio University Hospital (Sevilla, Spain)

  PRINCIPAL INVESTIGATOR

• Diego Penela, MD, PhD

  Ospedale Guglielmo da Saliceto (Piacenza, Italy)

  PRINCIPAL INVESTIGATOR

• Juan Fernández-Armenta, MD, PhD

  Puerta del Mar University Hospital (Cadiz, Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized, controlled and international multicenter study. All patients who fulfill the inclusion criteria will be consecutively enrolled and randomized on a 1:1 basis to each of the LAT annotation systems (WF vs. M-method) before the ablation procedure. Ablation will be directed to the earliest activation site identified with the assigned annotation system. Any change of the assigned annotation system during the procedure won't be allowed, thus being a reason for justifying study exclusion.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 14, 2017
• Study Start: June 26, 2018
• Primary Completion: May 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

ES (1)