Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
Sponsor: atHeart Medical LLC
Enrolling: Male and Female Patients
IRB Number: AAAT3703
U.S. Govt. ID: NCT04591392
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of a new device, called the Carag Bioresorbable SeptalOccluder (CBSO) device when used to treat Atrial Septal Defect (ASD). ASD is a condition that occurs at birth where there is a hole in the two upper chambers of the heart.
Investigator
Robert Sommer, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366