Using 3D echocardiography to guide mitral valve repair for degenerative disease
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
This study tests if using a special 3D imaging technique during surgery can help people with degenerative mitral valve disease have better repair outcomes and fewer problems afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 338 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05595226 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Real-time 3D transesophageal echocardiography (RT3D-TEE) on the outcomes of mitral valve repair in patients suffering from degenerative mitral valve disease. It aims to determine whether this guided approach can reduce surgical failure rates and the recurrence of mitral valve regurgitation within one year post-surgery. Participants will be randomly assigned to receive either the RT3D-TEE-guided repair or standard care, allowing for a comparison of outcomes. The study focuses on patients diagnosed with chronic primary degenerative mitral regurgitation as confirmed by preoperative echocardiograms.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic primary degenerative mitral regurgitation who can provide informed consent.
Not a fit: Patients who have had previous mitral valve surgeries or require concurrent cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced recurrence of mitral valve issues for patients.
How similar studies have performed: While the use of echocardiography in surgical guidance is established, the specific application of RT3D-TEE in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram. * Informed consent was obtained Exclusion Criteria: * Re-operation of mitral regurgitation * Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries. * Mitral valve replacement * Unable to undergo TEE
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital,Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.