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Clinical Trials/DRKS00010233
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.

Registry
who.int
Start Date
April 11, 2016
End Date
December 19, 2019
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Deutsches Herzzentrum München

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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