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Assessment of S-ICD Eligibility With 12-Lead ECG (EL-SID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209726
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University

Study Description
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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.

Condition or disease
Implantable Defibrillator User

Study Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of Subcutaneous Implantable Cardioverter Defibrillator Eligibility With 12-lead Electrocardiogram
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing ICD implantation for currently approved indications.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209726


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Larisa Tereshchenko
More Information
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Publications of Results:

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Responsible Party: Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03209726    
Other Study ID Numbers: STUDY00016034
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No