April 24, 2026 — Johnson & Johnson recently announced the initiation of the PERSIGMA randomized controlled trial (RCT), one of the first randomized studies evaluating competitive pulsed field ablation (PFA) technologies. In this rapidly advancing field, there is an increasing need for head-to-head data that provides insights on how different technologies influence outcomes in practice. PERSIGMA RCT reflects a deliberate step forward to generate clear, comparative evidence and bring greater rigor to how PFA technologies are evaluated.
Up to 466 participants across 50 sites will be randomly assigned to receive treatment with either VARIPULSE Pro Platform -the next-generation pulse sequence PFA- or the control FARAPULSE PFA platform1 in patients with persistent atrial fibrillation (AFib). VARIPULSE Pro received CE mark in March, and is not yet approved in the U.S. The study’s primary endpoints include safety, evaluated by the occurrence of primary adverse events, and effectiveness, defined by freedom from arrhythmia recurrences during the evaluation period of 60 days after the procedure.
The VARIPULSE Pro Platform is integrated with the CARTO System, a connected ecosystem that brings together imaging, mapping, and therapy. This evolution is driven through multigenerational innovative launches, including optimized irrigation rates and enhanced pulse sequences to further improve procedural efficiency and patient outcomesi,ii,iii,iv. It seeks to build on the platform’s proven precisionv,vi and safety profilevii supported by VARIPURE 12-month interim results, presented at the 2026 EHRA Congressviii. Additional real-world data was presented during HRS 2026ix,x,xi.
“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 Nair2, M.D., 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.
At Heart Rhythm 2026 Congress in Chicago, IL, Dr. Devi Nair presented one of the first cases from the PERSIGMA RCT trial during the Rhythm Theatre presentations, offering an early look at procedural experience with the study protocol and PFA technology.
“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,” said Andrea Natale3, M.D, F.A.C.C., F.H.R.S., F.E.S.C. Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center and Co‑National Study Principal Investigator of the PERSIGMA trial. “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.”
“Pulsed field ablation has advanced rapidly but not all technologies perform the same, and physicians make decisions without direct comparative data,” said Gregory Michaud, M.D., 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.”
With PERSIGMA RCT, the company 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.
For more information, visit J&J MedTech electrophysiology.
Footnotes
1. Trademarks listed are the property of their respective owners
2. Dr. Nair served as a study investigator and as a consultant for Johnson & Johnson. Dr. Nair was not compensated for this authorship contribution.
3. Dr. Natale served as a study investigator and as a consultant for Johnson & Johnson. Dr. Natale was not compensated for this authorship contribution.
i Almorad A, Sebag FS, Brix Kronborg M, et al. Acute safety, effectiveness and procedural workflow for the pulsed field ablation variable loop circular catheter in AF procedures: a prospective, multicenter, post-market clinical trial. Presented at: European Society of Cardiology (ESC) Congress; September 1, 2025; Madrid, Spain.
ii Porterfield C, Krishnan K, Saleem M, Steckman D, Ebinger M, Gampa A, et al. Real-world safety profile of a multi-electrode variable loop pulsed-field ablation catheter. Presented at: Kansas City Heart Rhythm Symposium 2025; August 16 2025; Overland Park (Kansas City), KS.
iii Zito E, Mansour M, Reddy VY, et al. Assessment of temperature dynamics in pulsed field ablation with a variable-loop circular catheter: a comparative analysis of waveform configurations and irrigation rates in specimens of bovine ventricular myocardium. Europace. 2025;27:euaf278. doi:10.1093/europace/euaf278.
iv VARIPULSE Pulse Field Ablations in an in vitro model: temperature characterization of sequence 2 at 30 mL/min vs commercial sequence 1 at 4 mL/min and 30 mL/min. Engineering report. Report No. 502270676.
v Di Biase L, Marazzato J, Gomez T, et al. Application repetition and electrode-tissue contact result in deeper lesions using a pulsed-field ablation circular variable loop catheter. Europace. 2024;26(9):euae220. doi:10.1093/europace/euae220.
vi Duytschaever M, De Potter T, Grimaldi M, et al. Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study. Circ Arrhythm Electrophysiol. 2023 Mar;16(3):e011780.
vii Almorad A, Vetta G, Della Rocca DG, et al. Real-world experience of atrial fibrillation ablation using a variable-loop circular catheter: a single-centre study. Europace. 2025;27(Suppl 1):i291.
viii Scherr D, Bessière F, Kronborg MB, et al; VARIPURE Investigators. Effectiveness of AF pulsed field ablation with a variable loop circular catheter: 12-month VARIPURE results. Presented at: PFA Summit: European Heart Rhythm Association (EHRA) Congress; April 11, 2025; Paris, France.
ix Metzl MD, Wasserlauf J, Joshi N, et al. Zero-exchange workflow with a variable loop PFA catheter and no dedicated mapping catheter improves procedural efficiency. Presented at: Heart Rhythm Society (HRS) 2026; April 23–26, 2026; Chicago, IL.
x Porterfield CP, Krishnan K, Khaykin Y, et al. Variable loop circular catheter pulsed field ablation in real-world practice: low complication rates across patient and procedural characteristics. Presented at: Heart Rhythm Society (HRS) 2026; April 24, 2026; Chicago, IL.
xi Porterfield CP, Munjal J, Hushion MJ, et al. The variable loop circular catheter real-world safety survey: VARISURE early results. Presented at: Heart Rhythm Society (HRS) 2026; April 23–26, 2026; Chicago, IL.
April 14, 2026 
