A Phase 4 interventional study of Automatic annotation of LAT (WF-method) and Manual annotation of LAT (M-method) in Ventricular Premature Complexes and Catheter Ablation, sponsored by Centro Medico Teknon. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Centro Medico Teknon · Phase 4, Interventional, and Treatment
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.
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 100 is above the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Centro Medico Teknon is the lead sponsor of 20 studies on the registry; 11 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
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
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.
Time frame: 12 months
Mapping time
Time frame: 12 months
Number of mapped chambers
Time frame: 12 months
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.
Time frame: 12 months
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).
Time frame: 12 months
Radiofrequency (RF) time
Time frame: 12 months
Number of RF applications
Time frame: 12 months
Acute procedure success
Complete elimination of the PVC at the end of the procedure.
Time frame: 12 months
Clinical success
Reduction of, at least, 80% in the 24-hour PVC burden 1 month after the procedure.
Time frame: 1 month
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2018 to primary completion in May 2020, 23 months.
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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