Assessment of S-ICD Eligibility With 12-Lead ECG

N/ACompletedNCT03209726

Larisa Tereshchenko106 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

106

Conditions

Implantable Defibrillator User

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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)

Time frame: at the day of ECG recording (cross-sectional study)

Data from ClinicalTrials.gov

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