Comparing imaging methods for heart valve disease assessment
Official title: Assessment of Left Ventricular Volumes and Strain and Assessment of Valvular Lesions Using Two- and Three-dimensional Echocardiography and Cardiac MRI, a Correlation Study
Run by The Cleveland Clinic · NCT04126018 · Data updated 2026-11-12
This study is testing whether a new 3D heart imaging method is better than the traditional 2D method for checking how serious heart valve problems are in people with conditions like aortic stenosis and mitral valve regurgitation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | August 23, 2019 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 13, 2026 |
| Trial ID | NCT04126018 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-90 with suspected moderate to severe mitral or aortic valve disease.
✕Probably not a fit
Patients with acute cardiac injuries, congenital heart diseases, or significant claustrophobia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the accuracy of 3D transthoracic echocardiography (TTE) with 2D TTE in evaluating the severity of valvular heart disease, specifically aortic stenosis, aortic regurgitation, and mitral valve regurgitation. It will use cardiac magnetic resonance (CMR) as the reference standard to assess left and right ventricular function and myocardial fibrosis. Participants will complete questionnaires and undergo follow-up assessments, including non-contrast cardiac MRI, to evaluate outcomes such as hospitalization and valve interventions. The study also seeks to determine if myocardial fibrosis severity can predict symptoms and treatment responses.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing and managing valvular heart disease, leading to better patient outcomes.
How similar studies have gone: Previous studies have shown promising results in using advanced imaging techniques for assessing heart conditions, suggesting this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-90 years of age * Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam. * Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction Exclusion Criteria: * Acute traumatic cardiac injury * Aortic dissection or aortic root rupture * Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD * Presence of A-V fistula or intracardiac shunts * Any contraindications to CMR * Moderate or severe dysfunction in multiple valves * Patients with significant claustrophobia
Where it's running
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Cleveland Clinic
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Deborah Kwon, M. D. — The Cleveland Clinic
- Study coordinator: Deborah Kwon, M. D.
- Email: kwond@ccf.org
- Phone: 216-444-8526
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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DELINEATE-Prospective: AI-assisted echocardiogram analysis for valve disease
This project will test whether an AI system can automatically analyze echocardiograms to help doctors detect valve problems in adults who get heart ultrasounds.
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Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
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Identifying sex-specific biological markers in valvular heart disease
This study is testing if special heart scans can help find different biological markers for men and women with aortic valve disease to improve treatment and recovery after surgery.
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Exercise and nutrition support before and after TAVI for older adults with aortic stenosis
This trial tests whether a personalized exercise program plus protein and iron supplements before and after a transcatheter valve replacement can help older adults with aortic stenosis recover better than standard care.
-
Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.