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

Quirónsalud

Status and phase: Completed; Phase 4

Conditions: Ventricular Premature Complexes; Catheter Ablation

Treatments: Device: Automatic annotation of LAT (WF-method); Device: Manual annotation of LAT (M-method)

Study type: Interventional

Funder types: Other

Identifiers

NCT03340922

Wavefront

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Automatic annotation of LAT (WF-method)

Experimental group

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.

Treatment:

Device: Automatic annotation of LAT (WF-method)

Manual annotation of LAT (M-method)

Active Comparator group

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.

Treatment:

Device: Manual annotation of LAT (M-method)