Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy (NCT03590730) | Clinical Trial Compass
TerminatedNot Applicable
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Stopped: The trial stopped prematurely because of enrollment challenges.
South Korea12 participantsStarted 2017-11-15
Plain-language 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.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.