NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210021

Registered date:07/04/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAtrial mitral regurgitation
Date of first enrollment25/06/2021
Target sample size10
Countries of recruitment
Study typeInterventional
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 OutcomeChanges of MR severity (grade 0-4) assessed by echocardiography within 3 months before registration and 3 months after surgery
Secondary OutcomeAortic 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 maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Hiroaki Sakamoto
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3097
E-mail sakamotoh@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Hiroaki Sakamoto
Address 2-1-1 Amakubo, Tsukuba, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3097
E-mail sakamotoh@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital