MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation (MANIaC-PVC)
Ventricular Premature Complexes, Catheter Ablation
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
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
Experimental
Active Comparator
Automatic annotation of LAT (WF-method)
Manual annotation of LAT (M-method)
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.