Circulation Publishes Positive Results from Field Medical’s Ventricular Catheter Ablation Study

Field Medical announced that Circulation has published six-month outcomes from the Ventricular Catheter Ablation Study (VCAS), the first-in-human evaluation of its FieldForce Ablation System for ventricular tachycardia (VT). Results were also presented as a late-breaking trial at the 20th Annual International Symposium on Ventricular Arrhythmias (VT Symposium).

VCAS is a prospective, multicenter feasibility trial evaluating the safety and performance of the FieldForce Ablation System in patients with VT. Unlike conventional approaches, the system delivers a proprietary high-voltage, short-pulse waveform designed to penetrate dense scar tissue while minimising thermal injury.

Key Findings:

82 per cent freedom from recurrent VT/VF or ICD therapy

98 per cent reduction in VT/VF burden (episodes)

11.5 per cent had a primary safety event with 0 therapy-related complications

"While this remains an initial feasibility study, the six-month outcomes are highly encouraging. Achieving 82 per cent freedom from recurrence and a 98 per cent reduction in arrhythmia burden with a nonthermal, tissue-selective energy is a meaningful result in VT therapy. Importantly, this is the first time we've seen evidence that PFA can reach deep, transmural scar tissue in the ventricle, a long-standing challenge with existing energy sources," said Vivek Reddy, M.D., co-principal investigator, lead author, and electrophysiologist at Mount Sinai, New York. "These findings give me cautious optimism that with continued refinement, this approach could represent an important advance in the treatment of scar-related VT."

With the U.S. Food and Drug Administration's (FDA) Breakthrough Device designation and acceptance into the FDA Total Product Life Cycle (TAP) Pilot Program, Field Medical is advancing this program toward a pivotal trial and a rigorous evaluation of high-voltage focal PFA in VT.