Skip to main content
OpenTrials
Completed

NCT Number: NCT03209726

Assessment of S-ICD Eligibility With 12-Lead ECG

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Implantable Defibrillator User

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Larisa Tereshchenko

Other

Registry information

Official study title

Assessment of Subcutaneous Implantable Cardioverter Defibrillator Eligibility With 12-lead Electrocardiogram

Acronym: EL-SID

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 6, 2017
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.