Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— Tailored-AF  

Official title:

Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702451
• Other study ID #: CLIPL-01-002
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: December 27, 2023

Study information

• Verified date: April 2024
• Source: Volta Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Dispersion ablation + PVI
Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation

Device:
• VX1
VX1-based dispersion mapping

Procedure:
• PVI
Pulmonary vein antrum isolation

Locations

Country	Name	City	State
Belgium	OLV Aalst	Aalst
Belgium	UZ Leuven	Leuven
France	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
Germany	Klinikum Coburg	Coburg
Germany	Städtisches Klinikum Karlsruhe	Karlsruhe
Germany	Deutsches Herzzentrum München	München
Netherlands	OLVG Amsterdam	Amsterdam
Netherlands	Isala Hartcentrum Zwolle	Zwolle
United States	Grandview Medical Center	Birmingham	Alabama
United States	Ohio State University	Columbus	Ohio
United States	Inova Fairfax	Falls Church	Virginia
United States	Ascension St. Vincent's	Jacksonville	Florida
United States	Northwell Health	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	New York Presbyterian Queens Hospital	Queens	New York
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Volta Medical	CardiaBase, Covance

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom 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	Freedom 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
Secondary	Freedom 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
Secondary	Incidence of complications (safety composite endpoint)	Incidence of complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event	12 months