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Serial biomarker AssesMent in adults after percutaneous clOSure of the Atrial septal defect

Serial biomarker AssesMent in adults after percutaneous clOSure of the Atrial septal defect - SAMOSA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47308
Enrollment
50
Registered
2015-07-17
Start date
2015-07-31
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

Atrial septal defect

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Scheduled to undergo percutaneous ASD closure in the Erasmus MC; - Capable of understanding and signing informed consent.

Exclusion criteria

Exclusion criteria: - Patients living abroad or who are not Dutch speaking; - Age 200 umol/L); - Failure of percutaneous ASD closure due to procedural problems.

Design outcomes

Primary

MeasureTime frame
Non-responders after percutaneous ASD closure will be defined as: - Sustained echocardiographic RV dysfunction after one year (eyeballing, right ventricular fractional area change 2.8 m/s).

Secondary

MeasureTime frame
The serial evolution of several variables will be investigated, in order to gain more insight in the pathophysiological consequences of volume-load reduction on the right heart: - Biomarkers: NT-proBNP and other biomarkers that may arise to be potentially important during the execution of this study. - Conventional echocardiography: RV dimensions, RV systolic function, LV dimensions, LV systolic and diastolic function; - Speckle tracking echocardiography: global and segmental longitudinal strain of the RV and LV.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)