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

Efficacy and safety of posterior leaflet extension with glutaraldehyde-treated autologous pericardial patch for atrial mitral regurgitation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210021
Enrollment
10
Registered
2021-04-07
Start date
2021-06-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial mitral regurgitation Atrial mitral regurgitation

Interventions

We enlarge the posterior leaflet of the mitral valve using an autologous pericardium treated with 0.615% glutaraldehyde for 3 minutes.

Sponsors

Sakamoto Hiroaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Changes of MR severity (grade 0-4) assessed by echocardiography within 3 months before registration and 3 months after surgery

Secondary

MeasureTime frame
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)

Contacts

Public ContactHiroaki Sakamoto

University of Tsukuba Hospital

sakamotoh@md.tsukuba.ac.jp+81-29-853-3097

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026