Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03340922
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2017-11-03
Brief Title:
MANual vs automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation
Sponsor:
Centro Medico Teknon
Organization:
Centro Medico Teknon
Study Overview
Official Title:
MANual vs automatIC Local Activation Time Annotation for Guiding Premature Ventricular Complex Ablation Procedures MANIaC-PVC Study A Randomized Multicenter Study
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MANIaC-PVC
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None