NCT03209726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3.5 years

First QC Date

July 3, 2017

Last Update Submit

February 25, 2021

Conditions

Implantable Defibrillator User

Outcome Measures

Primary Outcomes (1)

  • 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)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing ICD implantation for currently approved indications.

You may qualify if:

  • medical condition, predisposing patient to life-threatening ventricular arrhythmias, eligible for currently approved ICD indications for primary or secondary prevention of sudden cardiac death

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 29754992RESULT

  • 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.

    PMID: 32354451RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 6, 2017

Study Start

June 21, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

US(1)