Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
||atHeart Medical LLC
||Male and Female Patients
|U.S. Govt. ID:
||Kate Dalton: 347-514-3366 / firstname.lastname@example.org
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.
Robert Sommer, MD
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