Perceval Bioprosthetic Valve Post Marketing Surveillance
Not Applicable
- Conditions
- Replacement of diseased aortic valve or malfunctioning artificial aortic valve by open-heart operations
- Registration Number
- JPRN-UMIN000041629
- Lead Sponsor
- ivaNova Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria
Not provided
Exclusion Criteria
NA
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Safety Presence and occurrence rate of device deficiencies and adverse events on intra-surgery and during postoperative follow-up period
- Secondary Outcome Measures
Name Time Method 2) Effectiveness Postoperative improvement of Patient Symptoms and hemodynamics