Valvular Heart DiseaseNCT06937125
Evaluation of Valvular Heart Disease Using Cardiac CT
An observational study of Valvular Heart Disease, run by Toho University at 1 site in Japan.
Trial summary
The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis. 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- How many people
- 350 participants
- Where
- 1 siteJapan
- Study dates
- 12 Mar 2025to Mar 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted at 7 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.
Who may be able to join
- Patients with at least moderate valvular heart disease who had a cardiac CT with 64 or more rows
- 18 years of age or older
Who cannot join
- Less than 18 years old
- Acute VHD
- Infectious endocarditis
- Patients with post-VHD intervention
- Poor CT image quality for analyzing CT data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Toho University
Ōta-ku, Tokyo, 143-8540
Ethics Committee of the Toho University, 81+3-5763-6534, omori.rinri@ext.toho-u.ac.jp
About this study
Official title: Evaluation of Valvular Heart Disease: Multicenter Registry of Noninvasive Imaging Modalities by Cardiac CT
The EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis.
- Assessing the accuracy of cardiac CT in evaluating cardiac structure, volume, function, and myocardium in VHD patients.
- Comparing the severity, classification, and etiology (primary vs. functional) of VHD.
- Monitoring serial changes in VHD severity via echocardiography.
- Investigating the relationship between echocardiographic and CT-derived parameters.
- Examining the correlation between imaging findings, VHD interventions, and patient prognosis.
- Conditions
- Valvular Heart Disease
- Medical subject headings
- Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
the 1-year composite endpoint of all-cause death and major cardiac adverse events (MACE) including VHD intervention.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start12 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
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
- 350 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Toho University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hideki Koike, Toho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937125
- Sponsor's protocol ID
- A24904
- Status last verified
- Oct 2026
- First submitted
- 18 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Valvular Heart Disease: Multicenter Registry of Noninvasive Imaging Modalities by Cardiac CT
- ClinicalTrials.gov ID
- NCT06937125
- Acronym / sponsor ID
- A24904
- Conditions
- Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Toho UniversityUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Apr 2025 (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 EVIDENTIA Registry is a multicenter study designed to evaluate valvular heart disease (VHD) using cardiac CT. It aims to assess cardiac valve anatomy, function, and myocardial characteristics through detailed CT analysis.
- Assessing the accuracy of cardiac CT in evaluating cardiac structure, volume, function, and myocardium in VHD patients.
- Comparing the severity, classification, and etiology (primary vs. functional) of VHD.
- Monitoring serial changes in VHD severity via echocardiography.
- Investigating the relationship between echocardiographic and CT-derived parameters.
- Examining the correlation between imaging findings, VHD interventions, and patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted at 7 centers throughout Japan, with the goal of enrolling a total of approximately 300-350 cases.
Key inclusion criteria (2 listed)
- Patients with at least moderate valvular heart disease who had a cardiac CT with 64 or more rows
- 18 years of age or older
Key exclusion criteria (5 listed)
- Less than 18 years old
- Acute VHD
- Infectious endocarditis
- Patients with post-VHD intervention
- Poor CT image quality for analyzing CT data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the 1-year composite endpoint of all-cause death and major cardiac adverse events (MACE) including VHD intervention.
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
1 site 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, run by Toho University at 1 site in Japan.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hideki Koike, MD, PhD (81+3-3762-4151, hideki.koike@med.toho-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 1-year composite endpoint of all-cause death and major cardiac adverse events (MACE) including VHD intervention. (time frame: one year). 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 9 Oct 2026.