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EL-SID: Assessment of S-ICD Eligibility With 12-Lead ECG

Sponsor
Larisa Tereshchenko (Other)
Overall Status
Completed
CT.gov ID
NCT03209726
Collaborator
(none)
106
Enrollment
1
Location
42.3
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to develop an approach to determine eligibility for subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    106 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Assessment of Subcutaneous Implantable Cardioverter Defibrillator Eligibility With 12-lead Electrocardiogram
    Actual Study Start Date :
    Jun 21, 2017
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG [at the day of ECG recording (cross-sectional study)]

      Amplitudes of R- and T-waves (and R/T ratios) on a special ECG (recorded for Subcutaneous ICD eligibility assessment)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • medical condition, predisposing patient to life-threatening ventricular arrhythmias, eligible for currently approved ICD indications for primary or secondary prevention of sudden cardiac death
    Exclusion Criteria:

    • Acute medical condition (e.g. acute myocardial infarction, severe trauma, post-surgery, admitted to ICU)

    • End stage organ failure

    • Pregnancy

    • Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health and Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Larisa Tereshchenko

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT03209726
    Other Study ID Numbers:
    • STUDY00016034
    First Posted:
    Jul 6, 2017
    Last Update Posted:
    Mar 1, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 1, 2021