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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03590925
Other study ID # 4-2018-0075
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 21, 2018
Est. completion date June 30, 2024

Study information

Verified date June 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement of the quality of care in patients with ICM the rate of device therapy(ICD or CRT-D(Cardiac Resynchronization Therapy-Device)) 3 years
Secondary Improvement of the cardiovascular outcome of patients Cardiovascular outcome (cardiovascular death, Non-cardiovascular death) 3 years
Secondary Improvement of the cardiovascular outcome of patients Pattern of arrhythmia measured by EKG or echocardiography 3 years
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