Heart Rhythm 2026: Clinical Data Show Efficacy of Abbott’s Pulsed Field Ablation, Cardiac Pacing Tech

Abbott shared new late-breaking data from four studies demonstrating strong clinical outcomes across its pulsed field ablation (PFA) and conduction system pacing (CSP) portfolios for treating heart rhythm disorders. The company shared the results over the weekend at Heart Rhythm 2026 in Chicago.

The data include six-month results from the FlexPulse IDE study, which is evaluating complex atrial fibrillation (AFib) treatment using the TactiFlex Duo Ablation Catheter, Sensor Enabled, as well as new clinical evidence for posterior wall ablation with the Volt PFA System. Data were also presented for Abbott’s ASCEND CSP IDE trial for its investigational UltiSynq CSP implantable cardioverter-defibrillator (ICD) lead, as well as a first-in-human LEAP2 chronic early feasibility trial for the investigational AVEIR CSP leadless pacemaker system.

Positive Results for the TactiFlex Duo Ablation Catheter, Sensor Enabled

New six-month data from the FlexPulse IDE study show positive patient outcomes with the TactiFlex Duo Ablation Catheter, Sensor Enabled, and confirm the strong safety and efficacy profile demonstrated in the CE Mark study for complex AFib treatment. The catheter provides physicians with two energy modes to tailor therapy based on a patient’s complex disease or anatomy: radiofrequency, which uses heat energy that destroys tissue responsible for erratic heart signals, and PFA, which uses high-energy electrical pulses that destroy the cells causing abnormal heart rhythms.

The late-breaking six-month data for the 188-patient FlexPulse IDE study show:ⁱ

• The majority (87%) of patients reported freedom from documented arrhythmias.
• A high safety profile (98.3%) with no major safety events.
• The majority (93.3%) of patients were treated exclusively with PFA, indicating this energy source alone was successful in treating complex cases.
• Physicians efficiently treated their patients—93.9% needed no additional ablation after the first therapy round.

“The Abbott TactiFlex Duo catheter offers the convenience of seamlessly switching treatment between radiofrequency and pulsed field ablation based upon the patient’s anatomy and their personalized ablation plan,” said Jonathan P. Piccini, M.D., professor of medicine, Duke University Medical Center, who presented the late-breaking data at HRS. “While RF has long been a well-established ablation approach, with this study, we have been able to show the TactiFlex Duo’s point-to-point PFA is an effective approach for a significant number of our patients.”

The FlexPulse IDE study is designed to secure U.S. Food and Drug Administration (FDA) approval for the TactiFlex Duo. The catheter received the CE Mark in Europe earlier this year.

Outcomes for Investigational Conduction System Pacing Devices

Results from two late-breaking clinical trials evaluated Abbott’s investigational leadless and traditional pacing/defibrillation CSP technologies, which are designed to deliver left bundle branch pacing (LBBP)— an approach intended to more closely replicate the heart’s natural electrical activation. Both data presentations were simultaneously published in Heart Rhythm.

The ASCEND CSP IDE trial evaluated the investigational high-voltage UltiSynq CSP ICD lead, which is implanted in the left bundle branch (LBB) area or the right ventricle to deliver both pacing and defibrillation. The three-month data show UltiSynq CSP met the study’s pre-specified primary safety and effectiveness endpoints. Key findings included:ⁱⁱ

• A high safety profile (97.5%) with no lead-related major safety events reported.
• A high success rate (99%) meeting left bundle branch area pacing (LBBAP) criteria, which can be compared to results from previously reported trial(s). An 86% success rate was met using the more stringent LBBP or likely LBBP criteria. An average of less than one (0.9) repositioning attempt per patient was reported.
• 100% defibrillation success, with the majority (92.5%) achieving first shock success at 20J. No patients needed the ICD lead repositioned to be effectively defibrillated.
• Stable electrical performance at three months, with no inappropriate therapies delivered due to P-wave or T-wave oversensing.

“Physicians are increasingly using left bundle area pacing for pacemaker patients, because it is associated with improved physiological activation compared with traditional pacing on the right side of the heart,” said Rahul N. Doshi, M.D., professor of medicine at Arizona State University. “The data from the ASCEND trial show an ICD lead designed for physiologic pacing can support restoration of normal heart rhythms when placed in the left bundle branch area. These early results suggest the potential to extend the benefits of physiologic pacing to ICD patients in an efficient manner.”

Abbott also presented late-breaking results from a first-in-human clinical study evaluating its investigational AVEIR CSP leadless pacemaker system. The one-month data from the 19-patient study found a high implantation success rate along with:ⁱⁱⁱ

• Delivery of pacing that closely followed the heart’s natural electrical pathways.
• Reliable electrical performance and functioning at the time of implant and through the first follow-up month.
• Consistent communication between devices in a dual‑chamber pacemaker setting.

New Volt PFA System Data

Late-breaking six-month data from the Volt CE Mark Extension Cohort trial demonstrated positive outcomes for patients in whom the heart’s posterior wall was treated in addition to the standard treatment.

New data from the Volt CE Mark Extension Cohort trial show:^iv

• Physicians cited the device’s ease of use and intuitive design as contributors to efficiently treat their patients with fewer therapy applications (4.1 applications per vein and 10.7 per PWI on average) compared to other on-market PFA systems.
• A high safety profile with no reported patient or procedure-related complications.
• The Volt PFA System secured FDA approval and CE Mark in Europe last year.

“Treating abnormal heart rhythms is not a siloed or one-size-fits-all approach, which is why Abbott is creating a holistic cardiovascular portfolio that empowers physicians to care for a wide range of arrhythmias,” said Priya Jagasia, divisional vice president of regulatory, clinical, reimbursement and strategic initiatives at Abbott. “The data from these clinical trials serve as a cornerstone for the new innovations we’re developing to help people live healthier lives.”

The TactiFlex Duo Ablation Catheter, Sensor Enabled; AVEIR CSP Leadless Pacemaker System; and UltiSynq CSP are approved for investigational use only in the United States.

Abbott’s technologies span the spectrum of healthcare, with businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Its 122,000 employees serve people in more than 160 countries.

The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients and is the primary information resource on heart rhythm disorders. Its mission is to improve patient care by promoting research, education, and optimal healthcare policies and standards. Incorporated in 1979 and based in Washington, D.C., its membership consists of more than 9,000 heart rhythm professionals from 94 countries.

The Heart Rhythm Society’s annual Heart Rhythm meeting convenes 10,000 of the world’s clinicians, scientists, researchers, and innovators in cardiac pacing and electrophysiology. More than 2,000 international experts in the field serve as faculty for the 200-plus educational sessions, forums, symposia, and ceremonies, while over 110 exhibitors showcase their products and services.

References
ⁱ Piccini, J. (2026, April 25). Safety and Effectiveness of a Dual-Energy Focal Ablation Catheter to Treat Paroxysmal Atrial Fibrillation: 6-Month Results of the FlexPulse IDE Study [Late Breaking Podium]. Heart Rhythm, Chicago, IL, US.
ⁱⁱ Schaller, R. (2026, April 25) Safety and efficacy of a novel ICD lead for LBBAP: Results from the ASCEND CSP trial [Late Breaking Presentation]. Heart Rhythm Society 2026, Chicago IL, USA.
ⁱⁱⁱ Reddy, V. (2026, April 25) LEAP2: A first-in-human study of a chronically-implanted novel leadless pacemaker for conduction system pacing [Late Breaking Presentation]. Heart Rhythm Society 2026, Chicago IL, USA.
^iv Sanders, P. (2026, April 24). 6-Month Safety and Effectiveness of Balloon-Based PFA System Left Atrial Posterior Wall Ablation: Results from the Volt CE Mark Extension Cohort [Late Breaking Poster]. Heart Rhythm, Chicago, IL, US.