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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.

The ASCENT ASD trial has advanced to Stage 3 enrollment, following the review of data from the first 50 US and EU patients by the US Food and Drug Administration (FDA) and the French National Agency for Medicines and Health Products Safety (ANSM).

For more information, please visit www.clinicaltrials.gov – Trial Identifier: NCT04591392.

Research Data

The reSept ASD Occluder has been studied extensively in preclinical phase, with data published in EuroIntervention in 2018.

Clinical studies are ongoing, with data already presented at scientific conferences and published in medical journals:

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

Two-year follow-up data from the First-in-Human study have been published in EuroIntervention in 2022.

Additional data from the European patient registry study have been published in the Journal of Interventional Cardiology in 2022.