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Clinical Trials/NCT03209726
NCT03209726CompletedNot Applicable

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

Larisa Tereshchenko1 site in 1 country106 target enrollmentStarted: June 21, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
106
Locations
1
Primary Endpoint
Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Larisa Tereshchenko
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Larisa Tereshchenko

Associate Professor of Medicine

Oregon Health and Science University

Study Sites (1)

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