Q21.1
Conditions
Interventions
Group 1: Monitoring of patients with scheduled transcatheter closure of Secundum Atrial Septal Defects (ASD II) with Ceraflex-ASD-Occluder
Sponsors
Deutsches Herzzentrum München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Able to fluently speak and understand German language, existent ostium secundum atrial septal defect (ASD II), presence of a hemodynamically significant ASD II (right ventricular volume overload determined by transthoracic echo (TTE)), defect hole(s) to be covered by an available Ceraflex ASD device, sufficient margin to place the device, Informed Consent prior to treatment and willing to return for the post-treatment evaluation at the implanting institution after 6 month
Exclusion criteria
Exclusion criteria: presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early performance success, defined as the rate of a successful placement of the device and successful closure of the defect without major complication until the day of discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure | — |
Countries
Germany
Contacts
Public ContactAndreas Eicken
Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
Outcome results
None listed