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

Completed

Conditions: Atrial septal defect
10010394
10007510

Registration Number: NL-OMON47308

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

- Patients living abroad or who are not Dutch speaking;
- Age <18 years;
- Renal impairment (serum creatinine >200 umol/L);
- Failure of percutaneous ASD closure due to procedural problems.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Non-responders after percutaneous ASD closure will be defined as:<br /><br>- Sustained echocardiographic RV dysfunction after one year (eyeballing, right<br /><br>ventricular fractional area change <35%, TAPSE <17 mm);<br /><br>- Sustained high RV pressures after one year (measured by tricuspid<br /><br>regurgitation maximal velocity >2.8 m/s).</p><br>

Secondary Outcome Measures

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