Implantable Defibrillator User Clinical Trial
— EL-SIDOfficial title:
Assessment of Subcutaneous Implantable Cardioverter Defibrillator Eligibility With 12-lead Electrocardiogram
Verified date | February 2021 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective of this study is to develop an approach to determine eligibility for subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Larisa Tereshchenko |
United States,
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
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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