New Trial on IRE for Catheter Ablation
October 5, 2022
As we’ve discussed on this website, electrophysiology is a fast-growing and changing cardiology subspecialty. Technology in this field is incredibly advanced, and new techniques and methods are being developed to make catheter ablation more effective and less risky. One such potential advancement is known as irreversible electroporation or IRE. This technology has been used in other fields of medicine, and the first cardiac catheter ablation using IRE was performed as part of a clinical trial in Europe about two years ago. The technology has finally made it stateside, and Dr. Banker is the Principal Investigator for the AdmIRE trial for pulse field ablation on behalf of Biosense Webster, the device manufacturer.
So, what does the IRE advancement mean for patients getting a catheter ablation, and how does that make ablations even safer than they are today?
IRE destroys or ablates the problematic heart tissue using electrical fields that create pores in the cells. Using this technique minimizes the involvement of tissue surrounding the treatment area. Traditional cardiac catheter ablation uses heat or cold to destroy this tissue and, as a result, may damage surrounding tissue, including that of the esophagus or a phrenic nerve, as well as the connective tissue of the pulmonary vein.
While we do not have long-term data from US patients and have just opened the trial for this new technology, we do have data from Europe. This new method of catheter ablation shows excellent promise. It may further refine what is already a very safe and effective technique for improving or eliminating cardiac arrhythmias and, most significantly, atrial fibrillation or A-fib.
Dr. Banker’s Involvement
As a principal investigator or PI for this clinical trial titled: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE), Dr. Banker has a vital job. He plays a primary role in the design and integrity of the trial. He will also manage the trial to ensure robust data and practices yield independent and high-quality results.
The enrollment in the trial is estimated to be about 550 patients, and the goal date for completion is the summer of 2023. At this point, we will be able to bring you preliminary results, and if the treatment shows significant promise, we can expect a decision from the FDA shortly after that.
To keep tabs on the progress of this trial, we encourage you to visit: https://clinicaltrials.gov/ct2/show/NCT04524364. You can ask out for periodic updates from Dr. Banker on this blog.