Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect (ASCENT ASD STUDY)

Date Added
September 17th, 2021
PRO Number
Pro00111553
Researcher
John Rhodes

List of Studies


Keywords
Cardiovascular
Summary

Transcatheter closure of secundum ASD using a permanent implant is considered the standard of care for treatment of clinically significant ASD. Over the past twenty years, devices have evolved such that safety and effectiveness are equal or superior to surgical techniques while reducing the economic and psychological costs of care. Industry sources estimate that, globally, over half a million patients have received a septal occluder to treat atrial level shunts.

A key remaining drawback to all such devices is that they are permanent implants placed in a typically young population. Unlike surgical suture, which resorbs over time, all currently available septal occlusion implants are constructed with a metal framework that incorporates some amount of fabric-based material.

The reSept ASD Occluder is unique in that the framework of the implant is comprised of a bioresorbable material (PLGA) and is intended for use in patients with a clinically significant secundum ASD, who, in the judgment of their physician, require closure of the ASD and in whom a transcatheter approach is deemed appropriate.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

MINDS Imaging Ancillary Study

Date Added
September 1st, 2021
PRO Number
Pro00111435
Researcher
John Rhodes

List of Studies


Keywords
Heart
Summary

Adults with Cognitive Heart Disease (ACHD) now outnumber children with CHD. ACHD patients can demonstrate some neurocognitive deficits which may reduce their quality of life. The goal of this research is to determine if the mind's ability to resist damage of the brain can impact the development and neurocognitive outcomes in ACHD patients.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
headleyt@musc.edu



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