Comparison of a Novel Occluder Versus Traditional Occluder in Atrial Septal Defect: A Randomized Trial.

BACKGROUND: Traditional occluders for atrial septal defect have 2 drawbacks: incomplete endothelialization and difficulty in achieving atrial septum puncture post implantation. The novel occluder ReAces was designed to address these 2 clinical pain points. In this study, we aimed to compare the efficacy and safety of ReAces with a traditional Amplatzer-like atrial septal defect occluder. METHODS: This was a multicenter, randomized, parallel-controlled, noninferiority clinical trial. Patients with atrial septal defects were enrolled and randomly implanted with a ReAces or a traditional Amplatzer-like occluder. The primary outcome was complete closure rate at 12 months post implantation. The Migraine Disability Assessment scores before and after the procedure were recorded. RESULTS: Sixty-two patients were implanted with ReAces and 64 patients with a traditional occluder. At the 12-month follow-up, complete closure was achieved in 61 patients in the trial group (98.4%) and 63 patients in the control group (98.4%), which demonstrated noninferiority (95% CI, -4.4% to 4.3%). No severe adverse events occurred during 12 months of follow-up except a case of device dislodgement in the trial group. The thickness of the central region of ReAces at the 12-month follow-up was significantly lower than that of the traditional device (6.8±3.7 mm versus 12.2±5.2, P<0.0001). The trial group showed a significantly lower Migraine Disability Assessment score (0.4±2.4 versus 1.4±4.1, P=0.042) and a lower proportion of patients with a nonzero Migraine Disability Assessment score (5.6% versus 18.2%, P=0.042) at the 1-month follow-up. CONCLUSIONS: The efficacy of ReAces was noninferior to that of a traditional Amplatzer-like occluder for transcatheter atrial septal defect closure. ReAces had a thinner central region during the follow-up and a lower Migraine Disability Assessment score at the 1-month follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05371366.