severe pulmonary regurgitation
Conditions
Interventions
None listed
Sponsors
Umetsu Aki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The Product is for use in patients with severe pulmonary regurgitation who have previously undergone surgical repair or transcatheter intervention (balloon valvuloplasty) to the right ventricular outflow tract, and are in clinical need of a pulmonary valve replacement. However, it is intended for use in patients for whom surgical procedures pose a high risk, and for whom the Product is deemed to be the optimal treatment. Note that this product should not be used for patients who have an artificial valve or a right ventricle to pulmonary artery conduit implanted.
Exclusion criteria
Exclusion criteria: none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Proportion of patients with favorable hemodynamic function without valve reintervention at 1 year after the initial procedure 2)Procedure success rate at 30 days after the initial procedure 3)Device success rate up to 5 years after theinitial procedure 4)RVOT re-operation rate attributable to the Product up to 5 years after theinitial procedure 5)Re-interventation rate for the product up to 5 years after the initial procedure 6)Incidence of valve dysfunction up to 5 years after the initial procedure 7)Death due to any cause up to 5 years after the initial procedure 8)Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out (up to 5 years after the initial procedure) | — |
Contacts
Public ContactAki Umetsu
Medtronic Japan
Outcome results
None listed