May 8, 2020 – Results from a first-in-human early feasibility study (EFS) using a saline enhanced radiofrequency (SERF) thermal-ablation system to treat ventricular tachycardia (VT) is highly effective at eliminating VT in patients with an acute procedural success rate of 100 percent and shows acceptable initial safety. This was the result of the the study "Ablation Of Refractory Ventricular Tachycardia With A Heated-saline Needle Catheter For Enhanced Radiofrequency (SERF) Ablation With Creation Of Transmural Lesions: A First-in-man Feasibility Study" presented as a late-breaking trial at the Heart Rhythm Society (HRS) 2020 virtual meeting.
“Our data from the first-in-human EFS suggest a highly feasible approach to treating patients with recurrent VT that is resistant to other treatments,” said Lead Investigator, Douglas L. Packer, M.D., professor of medicine at the Mayo Clinic.
The SERF VT EFS is a groundbreaking, single-arm observational study designed to evaluate the safety and effectiveness of the Thermedical Durablate catheter to treat VT, a leading cause of sudden cardiac death worldwide. The target study population consists of patients who have failed all current forms of treatment including implantable cardioverter defibrillators (ICDs), medical therapy and other forms of ablation therapy. The Durablate catheter uses a needle electrode to deliver heated, degassed saline and radiofrequency energy into the tissue to more effectively treat the tissue causing the VT than a standard, conventional ablation catheter.
The study included 32 patients treated at six centers in the U.S. and Canada.
Five-month follow-up data demonstrate that more than half of the patients had no recurrent VT and more than 60 percent of the patients had their VT reduced by 90 percent or more. In contrast, for the six months prior to ablation, patients had a median of 40 ICD treatments (shock or antitachycardia pacing), which can significantly reduce quality of life. The Durablate catheter was used to deliver an average of 10 lesions per case and the average total procedure time was four hours and 42 minutes, which is significantly shorter than typical conventional RF procedures for patients of this nature.
The SERF VT EFS is underway in the U.S. at Mayo Clinic, Loyola University Medical Center and Vanderbilt University Medical Center, and in Canada at Southlake Regional Health Centre, Montreal Heart Institute and Quebec Heart and Lung Institute.
Find links to all the Heart Rhythm Society 2020 Late-Breaking Clinical Trials in Electrophysiology