Evaluation of the Improvement of Primary Prevention in Ischemic Cardiomyopathy Patients Using New Screening and Referring System (Advance-ICM)

• Conditions: Ischemic Cardiomyopathy

• Registration Number: NCT03590925
• Lead Sponsor: Yonsei University

Brief Summary

The patients who undergo ICD(implantable cardioverter defibrillator) implantation for the primary prevention of sudden cardiac death with severe LV(left ventricle) dysfunction (ejection fraction ≤ 40%) by ICM(idiopathic cardiomyopathy).

Indications for ICD implantation for primary prevention in accordance with 2016 revised Korean indication guideline on ICD implantation

* FU LVEF(Left Ventricular Ejection Fraction) ≤ 30% (at least 40 days post-myocardial infarction)

* FU LVEF 31\~35%, NYHA(the New York Heart Association) class II, III (at least 40 days post-myocardial infarction)

* FU LVEF ≤ 40%, NSVT(non-sustained ventricular tachycardia) (Holter), inducible VF(ventricular flutter) or sustained VT(ventricular tachycardia) at electrophysiological study (at least 40 days post-myocardial infarction)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-21
• Status Verified: 2018-06
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-16
• Last Update Submitted: 2018-07-16
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age 18-80 years
• Patients eligible for the indications for ICD implantation for primary prevention indication in accordance with 2016 revised Korean indication guideline on ICD implantation
• Patients should be managed by non-EP physician
• Patients who are willing to sign the informed consent
• Patients who are willing to receive the implantation and post-operative follow-up

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Exclusion Criteria

• Malignant tumor
• Life expectancy < 12 months
• Patients unable or unwilling to cooperate in the study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of the quality of care in patients with ICM	3 years	the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device))

Secondary Outcome Measures

Name	Time	Method
Improvement of the cardiovascular outcome of patients	3 years	Pattern of arrhythmia measured by EKG or echocardiography

Trial Locations

Locations (1)

Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of