Assessment of S-ICD Eligibility With 12-Lead ECG

NCT ID: NCT03209726

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-21

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Implantable Defibrillator User

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larisa Tereshchenko

OTHER

Sponsor Role lead

Responsible Party

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Larisa Tereshchenko

Associate Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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/j.compbiomed.2018.05.002. Epub 2018 May 8.

Reference Type RESULT
PMID: 29754992 (View on PubMed)

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.2020.01.016.

Reference Type RESULT
PMID: 32354451 (View on PubMed)

Other Identifiers

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STUDY00016034

Identifier Type: -

Identifier Source: org_study_id

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