Functional outcome and quality of life in adult congenital heart disease patients with prosthetic valves (PROSTAVA-study).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21400

Enrollment

600

Registered

2009-11-17

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Prosthetic Valves

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Adult Congenital Heart Disease patients with a prosthetic heart valve (both homografts, heterografts and mechanical valves in aortic, mitral, pulmonary or tricuspid position) who are included in the CONCOR database and who give informed consent for the study.

Exclusion criteria

Exclusion criteria: Inability to comply with primary endpoint measures (completion of quality of life questionary, VO2max). Pregnant patients will not be included, they may be included > 3 months after pregnancy.

Design outcomes

Primary

Measure	Time frame
1. VO2 max; 2. Quality of life.	—

Secondary

Measure	Time frame
Prosthetic valve related compliations.	—

Outcome results