We are proud to share that 100 patients have been enrolled in the ASCENT ASD study. The latest successful implant has been conducted at Nationwide Children’s Hospital in Columbus, Ohio. The ASCENT ASD trial is a research study to evaluate the safety and efficacy of the reSept ASD Occluder for a minimally invasive, transcatheter closure of atrial septal defects (ASDs).
An ongoing study
The ASCENT ASD study is currently enrolling patients in over 20 centers in the USA and in four centers in France and it will soon begin enrollment in Canada and in Switzerland. Please find a list of the participating centers here. The trial has been approved by the US FDA, the French ANSM, Health Canada and Swissmedic.
“Opting for innovation and joining a research trial is not a decision families take lightly, when it comes to your own child’s health, especially when long-standing devices are routinely available,” said Laurent Grandidier, atHeart Medical CEO. “We are sincerely grateful to the 100 families in the USA and in France and to their clinicians for taking the time to research and understand our approach and for eventually opting for it for their child.”
ASD closure
An ASD is a common heart defect generally present at birth: a hole in the wall, called septum, that separates the two upper chambers of the heart.
Designed for a gentle and natural approach to the heart structure, the reSept ASD occluder is the first transcatheter device for ASD closure with a bioresorbable, metal-free frame. reSept’s frame is made of fabric patches connected by bioresorbable filaments, to potentially enable future transseptal interventions and leave less metal in the heart for life.
Please follow the links for further information on ASDs.