SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias

Sponsor
National Heart Centre Singapore (Other)
Overall Status
Recruiting
CT.gov ID
NCT05508880
Collaborator
Duke-NUS Graduate Medical School (Other)
80
1
43
1.9

Study Details

Study Description

Brief Summary

This study essentially consists of the prospective collection of mapping data derived from patients undergoing clinically indicated 3D mapping procedures. There is no intervention. The mapping data is used to construct and/or validate new activation mapping algorithms but will not be used to direct clinical treatment of the patient.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cardiac arrhythmias are a common clinical problem in cardiology. Often, such arrhythmias can be effectively and permanently treated through catheter ablation.

    A key technology enabling the success of catheter ablation is activation mapping of cardiac arrhythmias. This refers to the construction of maps which depict the sequential activation of the cardiac chamber of interest. It is a fundamental electrophysiology technique, but at the same time, the principles behind activation map construction have not changed for decades.

    In brief, the way activation maps are constructed nowadays consists of the following steps:

    (i) Sequential acquisition of voltage signals throughout the cardiac chamber of interest, recording both the signal together with the location of the signal in 3D space (ii) Local activation time annotation of each of the acquired signals in relation to a so-called timing reference (iii) Depiction of the annotated activation time graphically as a so-called activation map, through which the mechanism of the arrhythmia can be understood and an appropriate ablation target chosen

    Following assignment of the LAT to each individual signal, the map is complete and can be used to discern the arrhythmia circuit to choose an appropriate ablation target.

    The objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinically indicated EP mapping and ablation procedures.

    Specific objectives:

    (i) Electrogram signature analysis. To use machine learning techniques to identify electrogram properties associated with specific conduction patterns.

    (ii) Intracardiac EGM summation. To integrate all acquired points into a global function that allows as precise a determination as possible of the period of isthmus conduction in re-entrant arrhythmias.

    (iii) Conduction velocity estimation. To algorithmically determine conduction velocity using proprietary techniques to wholly or partially reduce reliance on LAT annotation.This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    SIGIL: Signal Interpretation and Analysis In Real Life Cardiac Arrhythmias
    Actual Study Start Date :
    Oct 30, 2019
    Anticipated Primary Completion Date :
    May 30, 2023
    Anticipated Study Completion Date :
    May 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The overall objective of this study is to develop, refine and validate LAT-independent methods of activation map analysis using mapping data acquired from patients undergoing clinicallyindicated EP mapping and ablation procedures. [2 years]

      This study aims to collect the electroanatomic 3D maps from patients to develop novel mapping algorithms, but this map data is not used to direct clinical treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Patient undergoing a clinically indicated 3D mapping procedure for a cardiac arrhythmia

    2. Ability to provide informed consent

    Exclusion Criteria:
    • Patients who cannot provide informed consent will be excluded. Otherwise, there are no specific exclusion criteria.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Heart Centre Singapore Singapore Singapore 169609

    Sponsors and Collaborators

    • National Heart Centre Singapore
    • Duke-NUS Graduate Medical School

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Heart Centre Singapore
    ClinicalTrials.gov Identifier:
    NCT05508880
    Other Study ID Numbers:
    • 2019/2774
    First Posted:
    Aug 19, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022