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MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation (MANIaC-PVC)

Primary Purpose

Ventricular Premature Complexes, Catheter Ablation

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Automatic annotation of LAT (WF-method)
Manual annotation of LAT (M-method)
Sponsored by
Centro Medico Teknon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Premature Complexes focused on measuring premature ventricular complex, catheter ablation, activation mapping, wavefront

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Antonio Berruezo, MD, PhD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Automatic annotation of LAT (WF-method)

Manual annotation of LAT (M-method)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mapping time
Number of mapped chambers
Accuracy of a proposed algorithm for selection of first chamber to map
In the case of PVCs arising from ventricular outflow tracts, we propose an algorithm to avoid subjective criteria, and to deal with eventual wrong selection of the first mapped chamber, leading to unnecessary RF applications. This algorithm involves a step-by-step analysis of the PVC-ECG morphology: precordial R/S transition and presence of one or more of the following clinical items, which have been previously related with a left origin: male gender, hypertension, or age > 50 years.
Number of target points
Target point is defined as any suspected PVC-site of origin where RF is delivered according to mapping data. Therefore, for one case there can be found a single target point with multiple RF applications, or multiple target points with one single RF application. The maximum distance between 2 RF applications to be considered at the same target point will be defined as 5 mm (equivalent to a 1-cm2 area).
Radiofrequency (RF) time
Number of RF applications
Acute procedure success
Complete elimination of the PVC at the end of the procedure.
Clinical success
Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure.

Full Information

First Posted
November 3, 2017
Last Updated
October 17, 2020
Sponsor
Centro Medico Teknon
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1. Study Identification

Unique Protocol Identification Number
NCT03340922
Brief Title
MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation
Acronym
MANIaC-PVC
Official Title
MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures (MANIaC-PVC Study). A Randomized, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Medico Teknon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a prospective, randomized, controlled and international multicenter study. The investigators aim to analyze the accuracy of LAT annotation using a novel algorithmic method (Wavefront, CARTO, Biosense Webster, Diamond Bar, California, USA) (WF), based on automatic annotation of the maximal negative slope of the unipolar electrogram (U-EGM) within the window demarcated by the B-EGM, by comparison with conventional, manual annotation in a multicenter cohort of patients referred for PVC ablation. Further on, 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. The investigators hypothesize that automatic LAT annotation (using WF and the ECG recognition algorithm) could be superior to conventional, manual annotation in terms of mapping success and could reduce both procedure time and radiofrequency time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Premature Complexes, Catheter Ablation
Keywords
premature ventricular complex, catheter ablation, activation mapping, wavefront

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic annotation of LAT (WF-method)
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual annotation of LAT (M-method)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automatic annotation of LAT (WF-method)
Other Intervention Name(s)
Wavefront
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Manual annotation of LAT (M-method)
Other Intervention Name(s)
Manual
Intervention Description
Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.
Primary Outcome Measure Information:
Title
Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mapping time
Time Frame
12 months
Title
Number of mapped chambers
Time Frame
12 months
Title
Accuracy of a proposed algorithm for selection of first chamber to map
Description
In the case of PVCs arising from ventricular outflow tracts, we propose an algorithm to avoid subjective criteria, and to deal with eventual wrong selection of the first mapped chamber, leading to unnecessary RF applications. This algorithm involves a step-by-step analysis of the PVC-ECG morphology: precordial R/S transition and presence of one or more of the following clinical items, which have been previously related with a left origin: male gender, hypertension, or age > 50 years.
Time Frame
12 months
Title
Number of target points
Description
Target point is defined as any suspected PVC-site of origin where RF is delivered according to mapping data. Therefore, for one case there can be found a single target point with multiple RF applications, or multiple target points with one single RF application. The maximum distance between 2 RF applications to be considered at the same target point will be defined as 5 mm (equivalent to a 1-cm2 area).
Time Frame
12 months
Title
Radiofrequency (RF) time
Time Frame
12 months
Title
Number of RF applications
Time Frame
12 months
Title
Acute procedure success
Description
Complete elimination of the PVC at the end of the procedure.
Time Frame
12 months
Title
Clinical success
Description
Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years. Indication for PVC ablation. Signed informed consent. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Berruezo, MD, PhD
Organizational Affiliation
Centro Medico Teknon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Bisbal, MD, PhD
Organizational Affiliation
Hospital Universitari German Trias i Pujol (Badalona, Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alonso Pedrote, MD, PhD
Organizational Affiliation
Virgen del Rocio University Hospital (Sevilla, Spain)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diego Penela, MD, PhD
Organizational Affiliation
Ospedale Guglielmo da Saliceto (Piacenza, Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan Fernández-Armenta, MD, PhD
Organizational Affiliation
Puerta del Mar University Hospital (Cadiz, Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antonio Berruezo, MD, PhD
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16174026
Citation
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.
Results Reference
background
PubMed Identifier
19866350
Citation
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.
Results Reference
background
PubMed Identifier
7620643
Citation
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.
Results Reference
background
PubMed Identifier
24829224
Citation
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.
Results Reference
background
PubMed Identifier
22342861
Citation
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.
Results Reference
background
PubMed Identifier
25672982
Citation
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.
Results Reference
background
PubMed Identifier
23850913
Citation
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. Erratum In: J Am Coll Cardiol. 2014 Feb 25;63(7):746. Van Huls Vans Taxis, Carine [corrected to Van Huls Van Taxis, Carine].
Results Reference
background

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

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