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

• Conditions: Prosthetic Valves; Adult Congenital Heart Disease

• Registration Number: NL-OMON21400
• Lead Sponsor: etherlands Heart FoundationUniversity Medical Center GroningenICI

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 600

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

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. VO2 max;<br /><br>2. Quality of life.

Secondary Outcome Measures

Name	Time	Method
Prosthetic valve related compliations.