Harmony Transcatheter Pulmonary Valve Use-Results Surveillance
Not Applicable
- Conditions
- severe pulmonary regurgitation
- Registration Number
- JPRN-jRCT2002230001
- Lead Sponsor
- Oyanagi Takahiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
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
none
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method