COmprehensiVE assessment of peRcutaneous implanted pulmonary valve prostheses to determine the incidence of HALT. An exploratory study.

COmprehensiVE assessment of peRcutaneous implanted pulmonary valve prostheses to determine the incidence of *HALT*. An exploratory study. - COVER study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54990

Enrollment

Registered

2020-07-30

Start date

2020-09-22

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

PPVI endocarditis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Underwent PPVI - Age > 18 years

Exclusion criteria

Exclusion criteria: - Pregnancy - Unwillingness to sign informed consent - Known allergy to iodinated contrast material - Indication to perform prehydration prior to intravenous contrast material admin-istration according to the guidelines in the EMC - Unwillingness to be informed about unrequested findings on the CT

Design outcomes

Primary

Measure	Time frame
Incidence of HALT as detected by computed tomography CT on percutaneously implanted pulmonary prosthetic heart valves.	—

Secondary

Measure	Time frame
Secondary, the relation of blood biomarkers and MRI flow profiles to HALT. Incidence of HALT on TTE.	—

Countries

Netherlands

Outcome results