Assessment of S-ICD Eligibility With 12-Lead ECG

Implantable Defibrillator User Clinical Trial

— EL-SID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209726
• Other study ID #: STUDY00016034
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Implantable Defibrillator User

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)