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

NCT ID: NCT03590925

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-21

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Ischemic Cardiomyopathy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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new screening and referring system of ICD

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Boyoung Joung, MD, Ph.D

Role: primary

82-2-2228-8460

References

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Lee JH, Yu HT, Oh IY, Choi EK, Sung JH, Lee YS, Kim JY, Baek Y, Park J, Joung B; ADVANCE-ICM investigators. Clinical and Hospital Factors Affecting Treatment with Primary Prevention Implantable Cardioverter-Defibrillators in Ischemic Cardiomyopathy Patients. Yonsei Med J. 2020 Nov;61(11):942-950. doi: 10.3349/ymj.2020.61.11.942.

Reference Type DERIVED
PMID: 33107237 (View on PubMed)

Other Identifiers

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4-2018-0075

Identifier Type: -

Identifier Source: org_study_id

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