The U.S. Food and Drug Administration (FDA) has approved a clinical trial to assess the safety and effectiveness of a new type of ablation catheter for patients with drug-resistant ventricular tachycardia (VT) conventional antiarrhythmics or standard electrophysiology (EP) ablation procedures.
The single-arm open-label interventional trials will evaluate the Thermedical SERF Thermal Ablation System with the Durablate Catheter. SERF ablation provides a new form of biological heat transfer designed to be more efficient than conventional ablation methods, the vendor said. It delivers energy with a high level of precision to better control the size of the ablation and treat tissue deeper in the heart wall where life-threatening arrhythmias that cause VT are often found.
“We are grateful to the FDA for the rapid approval of this pivotal trial to evaluate our saline enhanced radiofrequency ablation (SERF) system in patients who are out of treatment options for their VT episodes and who suffer from an extremely poor quality of life,” explained Michael Curley, PhD, FHRS, in a report. He is co-founder and CEO of Thermal, and lead author of the first multicenter in-man trial evaluating SERF with the Durablate catheter, published in Circulation: arrhythmia and electrophysiology. “In our recent multicenter trial, 31 of 32 participants experienced immediate elimination of their clinical VT at the end of the procedure, and therapies such as shock or rhythm regulation were reduced by 89% during follow-up. five months in these patients.”
The Mayo Clinic in Rochester, Minnesota will be the first of 25 experimental sites in North America to enroll patients in the larger clinical trial. Douglas Packer, MD, a cardiac electrophysiologist at Mayo Clinic, is the principal investigator. To date, additional sites are planned in Birmingham, Boston, Charleston, Montreal, Nashville, Philadelphia and Quebec. The trial will enroll 154 participants with recurrent, sustained monomorphic VT that is resistant to drug therapy and conventional catheter ablation. Trial participants will undergo a SERF ablation procedure, with follow-up at seven days, one month, three months and six months.