Below, we are re-publishing with permission the press-release issued by AtriAN Medical on September 06, 2022
This follow-up trial builds on AtriAN’s initial safety and feasibility study and aims to assess the efficacy of its cardioneuroablation treatment in patients with atrial fibrillation.
GALWAY, Ireland, Sept. 6, 2022 /PRNewswire/ — AtriAN Medical today announced that it has completed enrollment of a second study using its selective pulsed field ablation (PFA) technology for the treatment of atrial fibrillation.
The Neural AF-2 study has enrolled cardiothoracic surgery patients with paroxysmal AF, utilizing AtriAN’s unique cardiac autonomic ablation technology to provide selective ablation of neuronal structures on the outside of the heart. A total of 12 patients were treated at Tbilisi Heart and Vascular Clinic (Georgia), with Prof Tamaz Shaburishvili as the Principal Investigator. Patients will be followed out to 1 year for AF recurrence.
The new study builds on AtriAN’s initial Neural-AF study that focused on safety, feasibility and acute outcomes, in twenty four patients undergoing concomitant coronary artery bypass grafting. The initial study was performed at Na Homolce Hospital in Prague (Czech Republic) and Tbilisi Heart and Vascular Clinic (Georgia). Data from that study was presented by Prof Vivek Reddy MD (Mount Sinai Hospital, NY) at the 2022 AF Symposium and by Prof Joris de Groot (Amsterdam UMC) at the European Heart Rhythm Association (EHRA) 2022 conference.
The original Neural-AF study was an all-comers design for CABG patients that did not focus specifically on patients with atrial fibrillation. The findings indicate that selective epicardial PFA of ganglionated plexi is feasible and safe. An acute extension in atrial tissue refractoriness was also recorded; this is a well recognized indicator of resistance to atrial fibrillation.
“The promising results from our first study have given us the confidence and momentum to expand into this second trial looking specifically at clinical outcomes in patients with AF” said AtriAN CEO Ken Coffey. “This will be a challenging cohort of patients but we look forward to providing them with improved outcomes and demonstrating the potential of our novel approach.”
The AtriAN system includes catheters designed for use within the pericardial space and a generator for providing low energy pulsed electric fields. In the near future, the company plans to conduct clinical studies to assess delivery of the treatment using sub-xiphoid minimally invasive access.
For more information about AtriAN Medical, please visit: www.atrianmedical.com
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