The PERSIGMA RCT pits the company’s Varipulse Pro PFA platform against the Boston Scientific Farapulse system. It compares the two leading PFA therapies in treating persistent AFib. Varipulse Pro, which recently received CE mark, remains investigational in the U.S., while Farapulse remains a leading PFA offering.
Johnson & Johnson said the head-to-head study aims to generate clear, comparative evidence and increase the rigor in PFA evaluation.
PERSIGMA will enroll up to 466 patients across 50 sites, randomizing them to either Varipulse Pro or Farapulse.
Varipulse Pro features a new pulse sequence designed to improve procedural efficiency while reinforcing safety and effectiveness. Johnson & Johnson said the new pulse sequence has a lower temperature profile, plus an ablation that comes in five times faster than the previous sequence, while still achieving equivalent lesions. The medtech giant built the technology on the proven Varipulse platform, which originally received CE mark in 2024.
Farapulse, a nonthermal treatment, uses electric fields to selectively ablate heart tissue. It delivers pulsed field energy with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. Boston Scientific’s VersaCross Connect access solution complements the sheath to provide safe and effective left heart access.
Johnson & Johnson said Dr. Devi Nair will feature one of the first cases from PERSIGMA at Heart Rhythm Society (HRS) 2026 in Chicago.
Commentary from Johnson & Johnson officials and study investigators
Devi Nair, the director of cardiac electrophysiology & research at St. Bernard’s Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas, and co-national study principal investigator of the PERSIGMA trial.
“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.”
Dr. Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, and co-national study principal investigator, said:
“PERSIGMA marks an exciting next phase in PFA research—moving the field forward with the rigorous, head-to-head evidence we need in persistent atrial fibrillation. As we broaden evaluation of PFA technology into more complex patient populations, studies like this are essential to helping physicians understand performance, refine procedural strategies, and ultimately improve outcomes for patients living with AFib.”
Dr. Gregory Michaud, chief medical and scientific officer, Electrophysiology, J&J, said:
“Pulsed field ablation has advanced rapidly but not all technologies perform the same, and physicians make decisions without direct comparative data. 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.”
