Assessment of S-ICD Eligibility With 12-Lead ECG

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03209726

Acronym

EL-SID

Enrollment

106

Registered

2017-07-06

Start date

2017-06-21

Completion date

2020-12-31

Last updated

2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable Defibrillator User

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results