Posterior leaflet extension with glutaraldehyde-treated autologous pericardial patch for atrial mitral regurgitation

JRCT ID: jRCTs031210021

Registered date:07/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial mitral regurgitation
• Date of first enrollment: 25/06/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): We enlarge the posterior leaflet of the mitral valve using an autologous pericardium treated with 0.615% glutaraldehyde for 3 minutes.

Outcome(s)

• Primary Outcome: Changes of MR severity (grade 0-4) assessed by echocardiography within 3 months before registration and 3 months after surgery

Secondary Outcome

Aortic cross-clamp time, serious postoperative complications (reoperation, neurological complications, prolonged mechanical ventilation, renal failure, mediastinitis), length of hospital stay, mortality rate
Changes of NYHA functional classification and serum BNP level within 3 months before registration and 3 months after surgery
Changes of parameters of transthoracic echocardiography within 3 months before registration, 1 week after surgery, and 3 months after surgery (Left ventricular function, left ventricular diameter / volume, left atrial diameter / volume, mean transmitral pressure gradients, peak systolic tricuspid pressure gradient)
Changes of parameters of of mitral valve by transesophageal echocardiography within 3 months before registration, during surgery, and 3 months after surgery (Effective MR orifice area, mitral valve area, leaflet length and angle, coaptation length)
Findings of exercise echocardiography 3 months after surgery (MR severity, mean transmitral pressure gradients, peak systolic tricuspid pressure gradient, left ventricular outflow tract pressure gradient, each parameter assessed before and after excersize)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with atrial MR of moderate (grade 2) or greater
2) Patients with heart failure symptoms of NYHA functional classification II or higher due to significant atrial MR even after optimal medications and have indication of surgery
3) Men and women over 20 years old
4) Patients with written informed consent

Exclude criteria

1) Patients with the following findings unsuitable for reconstrucion of mitral valve with autologous pericardial patch
1. Moderate or greater mitral valve stenosis
2. Severe mitral valve calcification
3. Severe pericardial calcification
2) Patients with severe left ventricular dysfunction (left ventricular ejection fraction <30%)
3) Patients with infections endocarditis
4) Patients with acute myocardial infarction within 30 days before surgery
5) Patients with severe lung disease (emphysema, chronic obstructive pulmonary disease, pulmonary fibrosis)
6) Patients with severe liver cirrhosis
7) Patients with a history of pericarditis
8) Women who are pregnant or may become pregnant
9) Patients who are judged inappropriate by the researcher

Related Information

• Primary Sponsor: Sakamoto Hiroaki
• Source(s) of Monetary Support: University of Tsukuba