Program Overview

ASCENT-ASD Investigational Device Exemption (IDE) Trial: atHeart Medical is enrolling patients in its pivotal IDE trial to demonstrate the safety and efficacy of the reSept™ ASD Occluder for treating clinically significant secundum ASD with a transcatheter approach as compared to pre-defined performance goals from other commercially available occluder devices. The prospective, single-arm, multi-site clinical investigation will enroll a total of up to 250 patients. For more information, please visit www.clinicaltrials.gov – Trial Identifier: NCT04591392.

Clinical Data

The reSept ASD Occluder has been studied in extensive preclinical studies, with data published in EuroIntervention 2017.

Data from the First-In-Human study were presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) Conference.