Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy

NCT03590730 | Terminated DMC

• 1 other identifier: 2017-08-027-007
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 12

Brief Summary

The prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography. Furthermore, the rheumatic valvular heart disease is much more prevalent in Asia than in Western countries, and the frequency of valve disease is higher in Asia. The effect of an implantable cardioverter defibrillator (ICD) in the primary prevention of sudden cardiac death in ischemic cardiomyopathy is well established and has become a standard of care. However, there is limited research on the effect of ICD implantation for primary prevention in patients with heart failure due to valvular heart disease. In a small study, the incidence of fatal cardiac arrhythmia was lower in patients with valvular cardiomyopathy (5%) who received ICD implantation for primary prevention than in those with ischemic cardiomyopathy. But there is also a report that the appropriate ICD treatment is not different from that of ischemic heart disease in valvular heart disease patients. Therefore, it is necessary to study the primary prevention effect of ICD on valvular cardiomyopathy in a larger number of patients. The purpose of this study was to investigate the effect of ICD on the prevention of sudden cardiac death in patients with heart failure due to valvular heart disease through prospective, multicenter, and observational studies.

Conditions

Valvular Heart Disease; Implantable Cardioverter Defibrillator; Sudden Cardiac Death; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Appropriate ICD therapy

  ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy

  Two year after study enrollment

Secondary Outcomes (3)

• Mortality

  Two year after study enrollment

• Incidence of inappropriate ICD therapy

  Two year after study enrollment

• Type of ventricular arrhythmia

  Two year after study enrollment

Study Arms (1)

Valvular heart disease

Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death.

Device: ICD implantation

Interventions

ICD implantation DEVICE

ICD will be implanted according to current guidelines recommendations.

Valvular heart disease

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* South Korean patients visiting the one of the investigator's study participating hospital will be enrolled. * Valvular cardiomyopathy patients with left ventricular ejection fraction ≤ 35% with symptoms of NYHA class II, III despite optimal medical treatment for more than 3 months according to the guideline recommendations for heart failure treatment and are expected to survive for more than one year.

You may qualify if:

• Patients who meet one of the following criteria:
• Patients who have undergone surgery for aortic valve or mitral valve disease for more than 12 months
• Patients with severe aortic valve or mitral valve disease
• Patients with left ventricular ejection fraction ≤ 35% by echocardiography or other imaging methods
• US, European practice guidelines class I indication for ICD implantation
• Patients without evidence of ischemic heart disease (who meet one of the following criteria):
• Stress test negative
• Significant stenosis was not observed in coronary artery images:
• epicardial coronary stenosis \<70%, left main stenosis \<50%
• History of heart failure symptoms
• Patients who have received medication for more than 3 months according to the heart failure treatment guideline recommendation

You may not qualify if:

• Patients with left ventricular dysfunction without valvular heart disease
• Patients who require cardiac pacing therapy due to bradycardia
• Heart transplant scheduled
• Life expectancy is less than one year

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead
• Medtronic: collaborator

Study Sites (12)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital

Daegu, 42415, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Mediplex Sejong Hospital

Incheon, 21080, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Cardiovascular Hospital

Seoul, 03722, South Korea

Location

Seoul Asan Medical Center

Seoul, 05505, South Korea

Location

Seoul Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seongwook Han, MD, Ph D

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 18, 2018
• Study Start: November 15, 2017
• Primary Completion: July 10, 2019
• Study Completion: July 15, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

KR (12)