ePTFE valve with Bulging Sinus

Clinical application of ePTFE (Gore-Tex) valve with Bulging Sinus - ePTFE valve with Bulging Sinus

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052180213

Enrollment

250

Registered

2019-03-27

Start date

2019-01-01

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

pulmonary valve regurgitation or stenosis (right ventricular outflow tract stenosis)

Interventions

Method Utilising the thermoplasticity of PTFE (Gore-Tex), a bulging sinus is formed in the PTFE (Gore-Tex) graft using a heating and pressurising device of our own design. Ten sizes are made at 2 mm i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who had congenital heart disease requiring reconstruction of the right ventricular outflow tract and underwent cardiac surgery using this valve with consent.

Exclusion criteria

Exclusion criteria: Patients who did not obtain consent.

Design outcomes

Primary

Measure	Time frame
We evaluate the valve function (regurgitation, mobility and stenosis) at 1, 3, 6, 12, 24, 36, 48 and 60 months after surgery with echocardiography or cardiac catheter.	—

Contacts

Public ContactShuhei Fujita

University Hospital, Kyoto Prefectural University of Medicine

fujishu@koto.kpu-m.ac.jp+81-75-251-5752

Outcome results

None listed

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