Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients

Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients - Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018396

Enrollment

Registered

2015-07-23

Start date

2013-03-01

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

congenital heart disease with pulmonary valve insuffucency

Interventions

pulmonary valve transplantation with decellularized heart valve for pulmonary valve insufficiency congenital heart disease patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for pulmonary valve replacement according to current medical guidelines in congenital heart disease Informed consent of parents (both) or patients, assent of patients (<18 years)

Exclusion criteria

Exclusion criteria: The patient has not provided Study informed consent. The patient has active endocarditis (within the last 3 month). The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyreoidism).

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and durability of the transplanted decellularized heart valve 3 month after the transplantation	—

Countries

Japan

Contacts

Public ContactHideto Ozawa

Osaka University hospital Cardiovascular surgery

h-ozawa@surg1.med.osaka-u.ac.jp06-6879-3154

Outcome results

None listed

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