DRKS00010233
Completed
Not Applicable
Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects - Ceraflex-ASD-Occluder
Deutsches Herzzentrum München0 sites149 target enrollmentApril 11, 2016
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Q21.1
- Sponsor
- Deutsches Herzzentrum München
- Enrollment
- 149
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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