Clinical Trial Finds Artificial Intelligence-Guided Procedure for Persistent Atrial Fibrillation Superior to Current Standard of Care
Trial results showed that a tailored cardiac ablation procedure supported by AI was a superior treatment for persistent and long-standing AF, challenging the current standard of care
2024 Press Release/Statements
Trial results showed that a tailored cardiac ablation procedure supported by AI was a superior treatment for persistent and long-standing AF, challenging the current standard of care
BOSTON, MA, MAY 18, 2024 – A transatlantic clinical trial, TAILORED-AF, compared an artificial intelligence (AI) software-guided (Volta AF-Xplorer™) ablation procedure in combination with pulmonary vein isolation (PVI) to conventional ablation targeting PVI alone for the treatment of persistent atrial fibrillation (AF). Trial results showed that a tailored cardiac ablation procedure supported by AI was a superior treatment for persistent and long-standing AF, challenging the current standard of care. Researchers presented these findings today as late-breaking clinical science during Heart Rhythm 2024.
Over 37 million people worldwide are living with AF, the most common type of arrhythmia1. Persistent AF occurs when an abnormal heart rhythm lasts for more than a week and long-standing persistent AF occurs when it extends greater than 12 months. Previous landmark studies looking at ablation strategies for persistent AF patients have demonstrated a lack of a consistent ablation strategy that is effective for patients, with a clinical success rate in past trials of 50%2. While PVI remains the cornerstone ablation procedure for paroxysmal AF, the optimal procedure for persistent and long-standing persistent AF is unknown.
In recent years, AI has significantly impacted the field of cardiac electrophysiology. AI can provide an individualized non-invasive approach to determine targets of ablation in persistent AF and determine arrhythmia risk in patients with heart disease3. The TAILORED-AF study, a randomized, two-arm clinical trial involving 26 centers in Europe and the United States, evaluated the effectiveness of an AI-guided cardiac ablation procedure compared to an ablation procedure with PVI alone for freedom of persistent AF. Patients were randomly assigned to receive the Anatomical arm (PVI-only) or the Tailored arm (AI-guided ablation with PVI) to assess the effectiveness of both treatment methods.
Researchers found that the Tailored arm was superior to the Anatomical arm. 88% of patients in the Tailored arm experienced freedom from AF 12 months post-procedure with or without anti-arrhythmic drugs, while 70% of patients in the Anatomical arm experienced freedom from AF. Additionally, 66% of patients in the Tailored arm experienced acute termination of AF compared to 15% of patients in the Anatomical arm. These results indicate that a more tailored approach, which includes AI-guided assessment, could represent a more effective procedure for patients with persistent and long-standing persistent AF than conventional methods.
"Atrial fibrillation is the most common arrhythmia and clinicians need more options, especially for hard-to-treat populations experiencing persistent AF," said Isabel Deisenhofer, MD, German Heart Center, Munich Department of Electrophysiology, Munich, Germany. “This is the first large-scale trial to show the benefit of an ECG-driven "PVI plus" procedure vs. standard-of-care in persistent AF patients. These results could have a real-world impact on how we treat persistent AF patients, especially those with longer AF duration."
Session Details
"Late Breaking Clinical Trials and Science - Innovation: Late Breaking Clinical Trials: Tailored Cardiac Ablation Procedure for Persistent Atrial Fibrillation Guided by Artificial Intelligence: The TAILORED-AF Randomized Clinical Trial" [Saturday, May 18, 2024, at 9:30 am ET]
1 Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. International Journal of Stroke. 2021;16(2):217-221.
2 Verma, Atul, et al. "Approaches to catheter ablation for persistent atrial fibrillation." New England Journal of Medicine 372.19 (2015): 1812-1822.
3 Kabra R, Israni S, Vijay B, Baru C, Mendu R, Fellman M, Sridhar A, Mason P, Cheung JW, DiBiase L, Mahapatra S, Kalifa J, Lubitz SA, Noseworthy PA, Navara R, McManus DD, Cohen M, Chung MK, Trayanova N, Gopinathannair R, Lakkireddy D. Emerging role of artificial intelligence in cardiac electrophysiology. Cardiovasc Digit Health J. 2022 Sep 27;3(6):263-275.
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The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal healthcare policies and standards. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 8,200 heart rhythm professionals from 94 countries. For more information, visit HRSonline.org.
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About Heart Rhythm 2024
The Heart Rhythm Society's annual Heart Rhythm meeting convenes 8,400+ of the world’s finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology. More than 1,200 international experts in the field will serve as faculty for the 200+ educational sessions, forums, symposia, and ceremonies, while 110+ exhibitors will showcase innovative products and services. For more information, visit www.HeartRhythm.com.