Long-Term Follow-Up of the Freestyle Stentless Bioprosthesis

Long-Term Follow-Up of the Freestyle Stentless Bioprosthesis - Freestyle Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40663

Enrollment

250

Registered

2014-11-25

Start date

2014-12-24

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aortic root pathology Aortic valve pathology

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Implantation of the Freestyle bioprosthesis in the LUMC

Exclusion criteria

Exclusion criteria: Explantation of Freestyle bioprosthesis

Design outcomes

Primary

Measure	Time frame
Structural valve detoriation	—

Secondary

Measure	Time frame
Valve-related mortality Valve related events (nonstructural valve dysfunction, valve thrombosis, thromboembolism, hemorrhage, valve endocarditis) Hemodynamic performance (effective orifice area, peak transvalvular gradient, LV mass reduction) Quality of life (physical health, mental health)	—

Countries

Netherlands

Outcome results