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

Yonsei University

Status: Enrolling

Conditions: Ischemic Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT03590925

4-2018-0075

Details and patient eligibility

About

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)

Enrollment: 300 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

300 participants in 1 patient group

new screening and referring system of ICD

Description:

Non-randomized, non-blinded, multi-center study receiving new screening and referring system of ICD