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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209726
Other study ID # STUDY00016034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 21, 2017
Est. completion date December 31, 2020

Study information

Verified date February 2021
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Larisa Tereshchenko

Country where clinical trial is conducted

United States, 

References & Publications (2)

Thomas JA, Perez-Alday EA, Hamilton C, Kabir MM, Park EA, Tereshchenko LG. The utility of routine clinical 12-lead ECG in assessing eligibility for subcutaneous implantable cardioverter defibrillator. Comput Biol Med. 2018 Nov 1;102:242-250. doi: 10.1016/ — View Citation

Wang L, Javadekar N, Rajagopalan A, Rogovoy NM, Haq KT, Broberg CS, Tereshchenko LG. Eligibility for subcutaneous implantable cardioverter-defibrillator in congenital heart disease. Heart Rhythm. 2020 May;17(5 Pt B):860-869. doi: 10.1016/j.hrthm.2020.01.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG Amplitudes of R- and T-waves (and R/T ratios) on a special ECG (recorded for Subcutaneous ICD eligibility assessment) at the day of ECG recording (cross-sectional study)
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