Clinical trial NCT03590730: Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Official title: Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Valvular Heart Disease
Implantable Cardioverter Defibrillator
Sudden Cardiac Death
Primary Prevention
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2018-07-18
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of Appropriate ICD therapy
timeFrame: Two year after study enrollment
Secondary outcomes:
measure: Mortality
timeFrame: Two year after study enrollment
measure: Incidence of inappropriate ICD therapy
timeFrame: Two year after study enrollment
measure: Type of ventricular arrhythmia
timeFrame: Two year after study enrollment
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Mediplex Sejong Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Seongwook Han, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References: