Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
NCT ID: NCT04702451
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
377 participants
INTERVENTIONAL
2021-02-12
2023-12-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tailored
Tailored ablation strategy
Dispersion ablation + PVI
Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1
VX1-based dispersion mapping
Anatomical
Anatomical ablation strategy
PVI
Pulmonary vein antrum isolation
Interventions
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Dispersion ablation + PVI
Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1
VX1-based dispersion mapping
PVI
Pulmonary vein antrum isolation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fortrea
INDUSTRY
CardiaBase
OTHER
Volta Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Isabel Deisenhofer, MD
Role: STUDY_CHAIR
Deutsches Herzzentrum Muenchen
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
Washington University
St Louis, Missouri, United States
Northwell Health
New York, New York, United States
New York Presbyterian Queens Hospital
Queens, New York, United States
Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Inova Fairfax
Falls Church, Virginia, United States
OLV Aalst
Aalst, , Belgium
UZ Leuven
Leuven, , Belgium
Pôle Santé République
Clermont-Ferrand, , France
Hôpital Saint Philibert
Lomme, , France
Hôpital Louis Pradel - Hospices Civils de Lyon
Lyon, , France
Hôpital Saint-Joseph
Marseille, , France
Hôpital Privé Jacques Cartier
Massy, , France
Hôpital Privé du Confluent
Nantes, , France
Clinique Saint George
Nice, , France
Centre Cardiologique du Nord
Saint-Denis, , France
Clinique Rhéna
Strasbourg, , France
Clinique Pasteur
Toulouse, , France
CHRU Nancy
Vandœuvre-lès-Nancy, , France
Klinikum Coburg
Coburg, , Germany
Städtisches Klinikum Karlsruhe
Karlsruhe, , Germany
Deutsches Herzzentrum München
München, , Germany
OLVG Amsterdam
Amsterdam, , Netherlands
Isala Hartcentrum Zwolle
Zwolle, , Netherlands
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLIPL-01-002
Identifier Type: -
Identifier Source: org_study_id
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