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parvalavular leak closure

Para-Prosthetic ValveLeak Closure Observatory-PVLC2 - EuroPVL Registry

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58460
Enrollment
50
Registered
2026-03-02
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Paravalvular leakage leakage of a heart valve

Interventions

Patients are asked to complete a quality of life questionnaire (EQ5D-5L) at baseline, after 1 month and after 3 months.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria:  - Patients aged 16 and more,- Patients not opposed to participate to the observatory, - Patients adressed for a paravalvular leak closure

Exclusion criteria

Exclusion criteria: - Patients aged less than16, - Patients unwilling to participate to the observatory or child’s legal representative if the patient is minor

Design outcomes

Primary

MeasureTime frame
Clinical success of the procedure:Living patientIn-place para-prosthetic prosthesisAbsence of surgical re-interventionAbsence of hospitalisation for heart failure in relation to para-prosthetic leakageAbsence of transfusion for anaemia in connection with haemolysis on para-prosthetic leakage

Secondary

MeasureTime frame
Technical success:Successful implantation of one or more valvular prosthesis with reduction of para-prosthetic valve leakage by at least one grade.Quality of life score EQ5D-5L pre-procedure and after between 1 month and 3 months

Countries

Belgium, France, Greece, Italy, Lithuania, Mexico, Netherlands, Poland, Spain, Turkey, United Kingdom

Contacts

Public ContactM.A.M. Beijk

Amsterdam UMC

m.a.beijk@amsterdamumc.nl0624434669

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026