Clinical trial NCT03340922: MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Premature Complexes
Catheter Ablation
Keywords: premature ventricular complex
catheter ablation
activation mapping
wavefront
Lead sponsor: Centro Medico Teknon
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rates of mapping success, using the assigned mapping approach (automatic vs. manual), as defined in description
timeFrame: 12 months
Secondary outcomes:
measure: Mapping time
timeFrame: 12 months
measure: Number of mapped chambers
timeFrame: 12 months
measure: Accuracy of a proposed algorithm for selection of first chamber to map
timeFrame: 12 months
measure: Number of target points
timeFrame: 12 months
measure: Radiofrequency (RF) time
timeFrame: 12 months
measure: Number of RF applications
timeFrame: 12 months
measure: Acute procedure success
timeFrame: 12 months
measure: Clinical success
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Antonio Berruezo, MD, PhD
Study officials:
affiliation: Centro Medico Teknon
name: Antonio Berruezo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari German Trias i Pujol (Badalona, Spain)
name: Felipe Bisbal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virgen del Rocio University Hospital (Sevilla, Spain)
name: Alonso Pedrote, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Guglielmo da Saliceto (Piacenza, Italy)
name: Diego Penela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Puerta del Mar University Hospital (Cadiz, Spain)
name: Juan Fernández-Armenta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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