Comparative study of postoperative functional mitral stenosis avoidance rate using flexible valvular band or semi-rigid valvular band in mitral annuloplasty for asymptomatic mitral regurgitation (FLEXMAP)

Active, not recruiting

• Conditions: primary mitral regurgitation

• Registration Number: jRCTs052220097

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-01
• Study Start: 2023-02-08
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Patients with a diagnosis of primary mitral regurgitation
2. Patients with a left ventricular ejection fraction (LVEF) of 50% or greater on echocardiography at the time of enrollment.
3. Patients who are able to give written consent to participate in the study of their own free will.
4. Patients who are at least 20 years old and less than 85 years old at the time of consent.

Exclusion Criteria

1. Patients with heart failure symptoms such as symptoms of exertional dyspnea due to primary mitral regurgitation
2. Patients with left ventricular enlargement
3. Patients with atrial fibrillation
4. Patients who are unable to perform exercise stress echocardiography due to orthopedic or other diseases
5. Patients undergoing emergency surgery for mitral regurgitation such as acute rupture of tendon cords
6. Patients with a diagnosis of moderate or severe aortic stenosis by echocardiography
7. Patients with moderate or severe aortic regurgitation diagnosed by either echocardiography, cardiac MRI or cardiac catheterization.
8. Patients diagnosed with moderate or severe aortic regurgitation by either echocardiography or cardiac MRI or cardiac catheterization
9. Patients who are participating or planning to participate in an interventional trial at the time consent is obtained
10. Other patients deemed inappropriate as research subjects by the principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Mean pressure gradient during exercise stress	6 months after surgery	Achievement of a mean pressure gradient of less than 10 mmHg

Secondary Outcome Measures

Name	Time	Method
Mean intraoperative pressure gradient		Mean intraoperative pressure gradient (transesophageal ultrasonography)
Mean pressure gradient at rest	2 weeks after surgery	Mean pressure gradient at rest
Achievement of a mean pressure gradient of less than 10 mmHg during exercise	2 weeks after surgery	Achievement of a mean pressure gradient of less than 10 mmHg during exercise
MR recurrence	6 months postoperatively	MR recurrence
Occurrence of major cardiovascular events (MACE)	6 months postoperatively	Occurrence of major cardiovascular events (MACE: cardiovascular death, myocardial infarction, or stroke)
Change from rest in mean pressure gradient during exercise	6 months postoperatively	Change from rest in mean pressure gradient during exercise