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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03590925

Enrollment

300

Registered

2018-07-18

Start date

2018-03-21

Completion date

2024-06-30

Last updated

2018-07-18

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

Conditions

Ischemic Cardiomyopathy

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Improvement of the cardiovascular outcome of patients	3 years	Cardiovascular outcome (cardiovascular death, Non-cardiovascular death)

Countries

South Korea

Outcome results