Johnson & Johnson Launches Landmark Head-to-Head Pulsed Field Ablation Trial in Persistent Atrial Fibrillation

Irvine, CA - April 24, 2026 - Johnson & Johnson today 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.

Johnson & Johnson is committed to continuously evolving its PFA portfolio. 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 outcomes^i,ii,iii,iv. It seeks to build on the platform's proven precision^v,vi and safety profile^vii supported by VARIPURE 12-month interim results, presented at the 2026 EHRA Congress^viii. Additional real-world data will be presented during HRS 2026^ix,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 will feature one of the first cases from the PERSIGMA RCT trial during the Rhythm Theatre presentations on Friday April 24th, 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."

Atrial fibrillation is the most common sustained cardiac arrhythmia and remains a significant public health challenge. It is a progressive disease that becomes more complex to treat over time. It often begins as paroxysmal atrial fibrillation with intermittent episodes that terminate spontaneously, and can advance to persistent atrial fibrillation, in which episodes last longer than seven days and typically require medical intervention to restore normal heart rhythm^xii.

"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.

Cardiovascular Solutions from Johnson & Johnson MedTech
Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit J&J MedTech electrophysiology.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to VARIPULSE Pro. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

© Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_GNTR_415410

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.

^xii Wiggins BS; ACC Solution Set Oversight Committee, Cibotti-Sun M, Moore MM. 2023 Atrial Fibrillation Guideline-at-a-Glance. J Am Coll Cardiol. 2024;83(1):280-284.doi:10.1016/j.jacc.2023.10.021

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