Assessment of S-ICD Eligibility With 12-Lead ECG
Completed
- Conditions
- Implantable Defibrillator User
- Registration Number
- NCT03209726
- Lead Sponsor
- Larisa Tereshchenko
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oregon Health and Science University
🇺🇸Portland, Oregon, United States