Valvular Heart disease Aortic valve stenosis, Aortic valve insufficiency,Pulmonary valve stenosis,Pulmonary valve insufficiency
Conditions
Interventions
A homograft heart valve obtained from a heart transplant recipient is transplanted into patients with valvular heart disease who are indicated for non-living donor-derived homograft valve replacement.
Eo4.100.520
Heart Valve Prosthesis Implantation
Sponsors
Fukushima Satsuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are under 80 years old at the time of consent. 2) Patients with valvular heart disease who are eligible for allogeneic valve transplantation from a non-living donor. 3) Patients who have provided written consent themselves or through a legally authorized representative (for minors).
Exclusion criteria
Exclusion criteria: 1) Patients with irreversible dysfunction of other organs. 2) Patients who are already participating in another clinical trial or are scheduled to participate during the study period. 3) Patients deemed ineligible for this study by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate of trial valve transplant recipients at 30 days post-transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints: 1) Change in left ventricular ejection fraction (LVEF) measured by echocardiography (Trial valve recipients: baseline, 30 days post-transplantation) 2) Change in NYHA functional classification (Trial valve recipients: baseline, 24 weeks post-transplantation) 3) Change in BNP levels (Trial valve recipients: baseline, 24 weeks post-transplantation) Safety Endpoints: 1) Rate of avoidance of reoperation due to trial valve dysfunction at 30 days post-transplantation (Trial valve recipients) 2) Survival rate of trial valve donors at 7 days post-harvest (To assess the safety of trial valve harvesting) 3) Number of adverse events related to trial valve transplantation (Trial valve recipients: up to 24 weeks post-transplantation) 4) Number of occurrences of trial valve dysfunction | — |
Contacts
Public ContactMayuko Ogawa
National Cerebral and Cardiovascular Center
Outcome results
None listed