Clinical trial NCT04702451: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Official title: Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Persistent Atrial Fibrillation
Catheter Ablation
Electrogram dispersion
Lead sponsor: Volta Medical
Sponsor class: INDUSTRY
Collaborators: name: Covance
name: CardiaBase
First posted: 2021-01-08
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Freedom from documented AF after one ablation procedure
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from documented AF/AT after one or two ablation procedures
timeFrame: 12 months
measure: Freedom from documented AF/AT after one ablation procedure
timeFrame: 12 months
measure: Incidence of complications (safety composite endpoint)
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Jacksonville
country: United States
facility: Ascension St. Vincent's
state: Florida
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Northwell Health
state: New York
city: Queens
country: United States
facility: New York Presbyterian Queens Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Aalst
country: Belgium
facility: OLV Aalst
city: Leuven
country: Belgium
facility: UZ Leuven
city: Clermont-Ferrand
country: France
facility: Pôle Santé République
city: Lomme
country: France
facility: Hôpital Saint Philibert
city: Lyon
country: France
facility: Hôpital Louis Pradel - Hospices Civils de Lyon
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Nice
country: France
facility: Clinique Saint George
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: Clinique Rhéna
city: Toulouse
country: France
facility: Clinique Pasteur
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Amsterdam
country: Netherlands
facility: OLVG Amsterdam
city: Zwolle
country: Netherlands
facility: Isala Hartcentrum Zwolle
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Isabel Deisenhofer, MD
role: STUDY_CHAIR
References:
citation: 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.
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.