ePTFE valve with Bulging Sinus

JRCT ID: jRCTs052180213

Registered date:27/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pulmonary valve regurgitation or stenosis (right ventricular outflow tract stenosis)
• Date of first enrollment: 01/01/2019
• Target sample size: 250
• Study type: Interventional

Intervention(s)

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 intervals from 6 to 24 mm according to the graft diameter. At the time of surgery we select a valve of appropriate size according to the physique and suture to the right ventricle outflow tract.

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who had congenital heart disease requiring reconstruction of the right ventricular outflow tract and underwent cardiac surgery using this valve with consent.
• Exclude criteria: Patients who did not obtain consent.

Related Information

• Primary Sponsor: Oda Shinichiro