Aortic valve reconstruction with autologous pericardium for patients with small aortic annulus

Aortic valve reconstruction with autologous pericardium for patients with small aortic annulus - Ozaki procedure for small aortic annulus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035804

Enrollment

Registered

2019-02-07

Start date

2016-08-29

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

severe aortic valve disease

Interventions

We will perform aortic valve resonstrcution using autologous pericardium in patients with severe aortic valve disease.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients having indication of aortic valve replacement due to severe aortic valve stenosis or insufficiency 2) Patients having the risk of prosthetic-patient mismatch (PPM) due to small aortic annulus

Exclusion criteria

Exclusion criteria: 1) Bicuspid aortic valve 2) Hemodialysis patients 3) Double or triple valve procedures

Design outcomes

Primary

Measure	Time frame
The following two primary outcomes are evaluated 3 months, 1 year and 3 years after operation; 1) freedom from postoperative prosthesis-patient mismatch rate, 2) freedom from readmission from heart failure.	—

Secondary

Measure	Time frame
The following five echocardiographic parameters are obtained 3 months, 1 year and 3 years postoperatively: 1) peak pressure gradient (mean pressure gradient), 2) effective orifice area (EOA), 3) EF%, 4) E/A, 5) E/e'	—

Countries

Japan

Contacts

Public ContactHiromi Wada

Shimane University Faculty of Medicine Division of Thoracic and Cardiovascular Surgery, Department of Surgery

hiromi03@med.shimane-u.ac.jp0853-20-2223

Outcome results

None listed

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