Estech has completed enrolling three patients for its Historic-AF European multi-center staged hybrid ablation clinical study.
The study will recruit over 100 persistent and long-standing persistent atrial fibrillation (AF) patients from France, Germany, Italy, Poland , and the UK.
The company will enroll patients by a two step procedure where the first step is to perform minimally invasive endoscopic epicardial ablation procedure using the Cobra Adhere XL device to remove the posterior left atrium.
After the ablation, a continuous loop monitor is implanted to continuously monitor the electrical activity of the heart.
The second stage is performed, after four to six weeks monitoring, using electrophysiological mapping and, if necessary, additional endocardial catheter ablation.
University of Brescia Medical School Civil Hospital cardiac surgeon Claudio Muneretto said their data indicate that even for the most difficult long-standing persistent AF patients, they have better than 85% freedom from AF throughout more than two years’ follow-up, confirmed by implanted continuous loop recorder data.
University of Brescia Medical School Civil Hospital electrophysiologist Antonio Curnis said they are excited about the staged hybrid solution with the Estech platform which provides them with many potential advantages including a more comprehensive lesion set, better lesion assessment, shorter procedure times for each discipline, fewer complications, and better outcomes.