Perceval Bioprosthetic Valve Post Marketing Surveillance

Perceval Bioprosthetic Valve Post Marketing Surveillance - Perceval Bioprosthetic Valve Post Marketing Surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041629

Enrollment

200

Registered

2020-09-04

Start date

2019-03-25

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

Replacement of diseased aortic valve or malfunctioning artificial aortic valve by open-heart operations

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are implanted with a Perceval Bioprosthetic Valve during the enrollment period

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
1) Safety Presence and occurrence rate of device deficiencies and adverse events on intra-surgery and during postoperative follow-up period	—

Secondary

Measure	Time frame
2) Effectiveness Postoperative improvement of Patient Symptoms and hemodynamics	—

Countries

Japan

Contacts

Public ContactSusumu Eguchi

LivaNova Japan K.K. Clinical and Scientific Affairs

Susumu.eguchi@livanova.com+81-3-3595-7630

Outcome results