Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation (Tailored-AF)

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI).

The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Dispersion ablation + PVI; Device: VX1; Procedure: PVI

• Study Type: Interventional
• Enrollment (Actual): 377
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Aalst
  • Leuven, Belgium, 3000
    • UZ Leuven
• France
  • Clermont-Ferrand, France, 63000
    • Pôle Santé République
  • Lomme, France, 59462
    • Hôpital Saint Philibert
  • Lyon, France, 69677
    • Hôpital Louis Pradel - Hospices Civils de Lyon
  • Marseille, France, 13008
    • Höpital Saint-Joseph
  • Massy, France, 91300
    • Hôpital Privé Jacques Cartier
  • Nantes, France, 44200
    • Hopital prive du Confluent
  • Nice, France, 06105
    • Clinique Saint George
  • Saint-Denis, France, 93200
    • Centre Cardiologique du Nord
  • Strasbourg, France, 67000
    • Clinique Rhéna
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Vandœuvre-lès-Nancy, France, 54511
    • CHRU Nancy
• Germany
  • Coburg, Germany, 96450
    • Klinikum Coburg
  • Karlsruhe, Germany, 76133
    • Städtisches Klinikum Karlsruhe
  • München, Germany, 80636
    • Deutsches Herzzentrum München
• Netherlands
  • Amsterdam, Netherlands, 1091
    • OLVG Amsterdam
  • Zwolle, Netherlands, 8025
    • Isala Hartcentrum Zwolle
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Ascension St. Vincent's
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University
  • New York
    • New York, New York, United States, 10075
      • Northwell Health
    • Queens, New York, United States, 11355
      • New York Presbyterian Queens Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 years of age or older candidates for a first AF ablation
• Symptomatic AF, refractory to at least one antiarrhythmic medication
• Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and < 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
• Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
• Patients must be able and willing to provide written informed consent to participate in the clinical trial
• At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months

Exclusion Criteria:

• Paroxysmal and short-standing AF < 3 months
• Long-standing persistent AF > 5 years (≥ 1 year in the United States)
• ≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
• Severe obesity (BMI > 40)
• Very dilated Left Atrium (LA)(e.g. LA diameter > 60 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
• Patients with AF secondary to an obvious reversible cause
• Inadequate anticoagulation as defined in the inclusion criteria
• LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
• Contraindications to anticoagulation (heparin, warfarin or NOAC)
• Patients who are or may potentially be pregnant
• Previous surgical or catheter ablation for AF
• Any cardiac surgery within the past 2 months (60 days) (includes PCI)
• Myocardial infarction within the past 2 months (60 days)
• Previous atrioventricular valve surgery
• History of blood clotting or bleeding abnormalities
• Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
• Rheumatic Heart Disease
• Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
• Unstable angina within the past month
• Acute illness or active systemic infection or sepsis
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Diagnosed atrial myxoma
• Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
• Enrollment in an investigational study evaluating another device, biologic, or drug
• Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
• Life expectancy or other disease processes likely to limit survival to less than 12 months
• Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored; Tailored ablation strategy	Procedure: Dispersion ablation + PVI; Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation; Device: VX1; VX1-based dispersion mapping
Active Comparator: Anatomical; Anatomical ablation strategy	Procedure: PVI; Pulmonary vein antrum isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Free From Documented AF After One Ablation Procedure	Freedom from documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures	Freedom from documented AF/AT episodes > 30 seconds, after one or two procedures, with or without AADs, at 12 months	12 months
Number of Participants Free From Documented AF/AT After One Ablation Procedure	Freedom from documented AF/AT episodes > 30 seconds, with or without AADs, 12 months after a single ablation procedure	12 months
Number of Participants With Complications (Safety Composite Endpoint)	Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event	12 months

Collaborators and Investigators

• Sponsor: Volta Medical
• Collaborators: CardiaBase; Fortrea
• Investigators: Study Chair: Isabel Deisenhofer, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

General Publications

• Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.
• Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.
• Deisenhofer I, Albenque JP, Busch S, Gitenay E, Mountantonakis SE, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Jan Smit J, Mohr Durdez T, Milpied P, Appetiti A, Guerrero D, De Potter T, De Chillou C, Goldbarg S, Verma A, Hummel JD; TAILORED-AF Investigators. Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial. Nat Med. 2025 Apr;31(4):1286-1293. doi: 10.1038/s41591-025-03517-w. Epub 2025 Feb 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Estimated): January 8, 2021

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Catheter Ablation; Persistent Atrial Fibrillation; Electrogram dispersion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: CLIPL-01-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No