Valvular Heart DiseaseBEATNCT03590730
Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
An observational study of Valvular Heart Disease and Implantable Cardioverter Defibrillator, run by Keimyung University Dongsan Medical Center at 12 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Valvular Heart Disease, Implantable Cardioverter Defibrillator, Sudden Cardiac Death
- What is being tested?
- ICD implantation
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 15 Nov 2017to 15 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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):
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
Daegu, 41944
Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
Daegu, 42415
Chonnam National University Hospital
Gwangju, 61469
Mediplex Sejong Hospital
Incheon, 21080
Seoul National University Bundang Hospital
Seongnam, 13620
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Severance Cardiovascular Hospital
Seoul, 03722
Seoul Asan Medical Center
Seoul, 05505
Seoul Samsung Medical Center
Seoul, 06351
Seoul St. Mary's Hospital
Seoul, 06591
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
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
- Being tested
- ICD implantation
- Medical subject headings
- Heart Valve Diseases, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantationDevice
ICD will be implanted according to current guidelines recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Valvular heart disease | Patients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death. Receives: Device: ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Appropriate ICD therapy
ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy
Measured: Two year after study enrollment
Secondary outcomes (3)
Mortality
mortality was recorded and it will be classified into cardiogenic/non-cardiogenic death. Especially, arrhythmic death was recorded separately.
Measured: Two year after study enrollment
Incidence of inappropriate ICD therapy
Inappropriately delivered ICD therapy (eg. ICD therapy delivered during sinus tachycardia)
Measured: Two year after study enrollment
Type of ventricular arrhythmia
Analyze the type of ventricular arrhythmia
Measured: Two year after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start15 Nov 2017
- Primary completion10 Jul 2019
- Study completion15 Jul 2021
Why it stopped: The trial stopped prematurely because of enrollment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Seongwook Han, MD, Ph D, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590730
- Sponsor's protocol ID
- 2017-08-027-007
- Acronym
- BEAT
- Status last verified
- May 2023
- First submitted
- 2 Jul 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03590730
- Acronym / sponsor ID
- BEAT / 2017-08-027-007
- Conditions
- Valvular Heart Disease, Implantable Cardioverter Defibrillator, Sudden Cardiac Death, Primary Prevention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The trial stopped prematurely because of enrollment challenges.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valvular heart disease | – | Device: ICD implantationPatients with left ventricular dysfunction due to valvular heart disease who received ICD implantation for primary prevention of sudden cardiac death. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Patients who meet one of the following criteria:
- 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):
- epicardial coronary stenosis <70%, left main stenosis <50%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD implantationICD will be implanted according to current guidelines recommendations. | Device | Valvular heart disease |
Primary outcome
Incidence of Appropriate ICD therapy
Time frame: Two year after study enrollment
ICD therapy that effectively terminate life-threatening arrhythmia: anti-tachycardia pacing, shock therapy
3 secondary outcomes
Mortality
Time frame: Two year after study enrollment
Incidence of inappropriate ICD therapy
Time frame: Two year after study enrollment
Type of ventricular arrhythmia
Time frame: Two year after study enrollment
Results and safety
The study was stopped early (reason given: The trial stopped prematurely because of enrollment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seongwook Han, MD, Ph D principal investigator
Keimyung University Dongsan Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease and Implantable Cardioverter Defibrillator, run by Keimyung University Dongsan Medical Center at 12 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The trial stopped prematurely because of enrollment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Appropriate ICD therapy (time frame: Two year after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.