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

JRCT ID: jRCTs052220097

Registered date:01/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: primary mitral regurgitation
• Date of first enrollment: 08/02/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): non blinded randamization

Outcome(s)

• Primary Outcome: Achievement of a mean pressure gradient of less than 10 mmHg during exercise stress 6 months after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include 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.

Exclude 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.
7) Patients diagnosed with moderate or severe aortic regurgitation by either echocardiography or cardiac MRI or cardiac catheterization
8) Patients who are participating or planning to participate in an interventional trial at the time consent is obtained
9) Other patients deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Kobayashi Takuma