Johnson & Johnson Begins Head-to-Head PFA Trial of Varipulse Pro

Johnson & Johnson has initiated the PERSIGMA randomized controlled trial (RCT), one of the first randomized studies assessing competitive pulsed field ablation (PFA) technologies.

Up to 466 subjects at 50 study sites will be randomly assigned to receive treatment with either J&J’s Varipulse Pro platform or the control Farapulse PFA platform in patients with persistent atrial fibrillation (AFib). Varipulse Pro earned CE mark clearance in March, and isn’t yet approved in the U.S.

The study’s primary endpoints include safety (evaluated by occurrence of primary adverse events) and effectiveness (freedom from arrhythmia occurrences during the evaluation period of 60 days after the procedure).

Varipulse Pro is integrated with the Carto system, a connected ecosystem that merges imaging, mapping, and therapy. This evolution, according to J&J, was driven through multigenerational launches, including optimized irrigation rates and enhanced pulse sequences to further improve procedural efficiency and patient outcomes.

“Having this head-to-head study to compare pulsed field ablation technologies is extremely important for the electrophysiology community since it will help us better understand how they perform relative to one another and make more informed treatment decisions in daily practice,” said Devi Nair, MD, FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard’s Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas, and Co-National Study Principal Investigator of the PERSIGMA trial.

With PERSIGMA RCT, the company said it will continue to grow the body of research supporting its electrophysiology portfolio to strengthen the evidence base for PFA and help improve outcomes for patients living with atrial fibrillation.

“Pulsed field ablation has advanced rapidly but not all technologies perform the same, and physicians make decisions without direct comparative data,” said Gregory Michaud, MD, chief medical and scientific officer, Electrophysiology, Johnson & Johnson. “We are confident in our PFA technology, our innovation pipeline and in the strength of our integrated portfolio. With PERSIGMA RCT, we are raising the bar to better understand how different PFA technologies perform in patients with persistent AFib and expand the indication to a broader patient population.”