CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Automatic annotation of LAT (WF-method) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03340922
NCT03340922Phase 4Completed
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MANual vs. automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures (MANIaC-PVC Study). A Randomized, Multicenter Study

Centro Medico Teknon·interventional·Posted Nov 14, 2017·Updated Oct 20, 2020

In Brief

A Phase 4 clinical trial evaluating Automatic annotation of LAT (WF-method) and Manual annotation of LAT (M-method) for Ventricular Premature Complexes and Catheter Ablation. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Premature Complexes, Catheter Ablation
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartJun 26, 2018
Primary CompletionMay 31, 2020
Study CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.6 years ago

Interventions

Automatic annotation of LAT (WF-method)device

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.

Manual annotation of LAT (M-method)device

Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.