Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation (FACIL AF)

Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and different rates and types of complications. (2) The efficacy over a mean follow-up of one year with cryoablation for AF is comparable to that of radiofrequency ablation in a prospective randomized trial, with a lower major complication rate (3, 4). In recent years, AF cryoablation has established itself as a real alternative to RF ablation, to the point that this ablative source is chosen in one out of five European patients undergoing PV isolation. 70-80% of patients maintain sinus rhythm after a first procedure, showing an efficacy rate equivalent to ablation by RF. It is also comparable to RF when it comes to safety. Phrenic nerve palsy remains the major concern of cryoablation, accounting for 40% of periprocedural complications. A reduction in total procedure time and less dependence on the operator's experience make cryoablation an attractive choice for centres starting an AF ablation program. In conclusion, we do not yet have definitive data to affirm the superiority of one energy source over the other. Generally the choice depends on the availability of the centre and on the experience of the operator.

Pulse field ablation (PFA): Vivek Y. Reddy demonstrates that in patients with paroxysmal atrial fibrillation, PFA rapidly and efficiently isolates PVs with a degree of tissue selectivity and a safety profile(1).PFA can achieve a high degree of durable PV isolation with a comparable efficiency than another techniques (RF or CRYO) at one year follow-up (2) Cryoablation has been a recognised technique for the ablation of atrial fibrillation for many years, with many studies comparing the technique to radiofrequency ablation with equal results. Studies are underway to compare radiofrequency AF ablation versus PFA (BEAT-AF study). A randomized study to compare two methods of cryoablation versus PFA will be necessary to validate the non-inferiority of the technique.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Device: Cryoballoon pulmonary vein isolation; Device: Pulse field ablation

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Chu Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is of legal age to participate in the study (age >18 years)
• The patient is eligible for ablation of paroxysmal atrial fibrillation
• The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
• The patient is able and willing to return for required follow-up visits and examinations

Exclusion Criteria:

• Previous AF ablation
• Persistent and permanent AF
• The patient is contraindicated or allergic to oral anticoagulation
• The patient or legal representative is enable to understand and willing to provide written informed consent to participate in the trial
• The patient is enable and willing to return for required follow-up visits and examinations
• Pregnant or nursing patient
• Patient in exclusion period of another interventional study,
• Patient under administrative or judicial supervision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cryoablation arm; Market approved cryoablation system	Device: Cryoballoon pulmonary vein isolation; ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation
Experimental: PFA arm; Market approved PFA ablation system (Farapulse - Boston Scientific system).	Device: Pulse field ablation; ablation of paroxysmal atrial fibrillation by Pulse field ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of subjects experiencing one-year single-procedure clinical success	successful index of AF ablation, absence of atrial arrhythmia recurrence on any type of recording (30 sec by TTM (event monitor), holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), absence of use of class I or III AAD.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life	SF-12 questionnaire.	6 and 12 months
Improvement in AF-specific quality of life	AFEQT questionnaire	6 and 12 months
Proportion of patients with death	Death from any causes	12 months
Proportion of patients with first hospitalization for cardiovascular causes.	First hospitalization for cardiovascular causes	12 months
Proportion of patients with acute complication related to the procedure	tamponade, stroke, myocardial infarction, other	during the procedure or one day after
Total procedure duration	Procedure duration in minutes	during the procedure
Total time of fluoroscopy	Total time of fluoroscopy in minutes	during the procedure
Proportion of patients with embolic events from arrhythmia	Stroke	12 months
Long term complications related to the procedure	phrenic palsy, pulmonary vein stenosis, pericarditis, other	12 months
Recurrence of atrial fibrillation	Absence of atrial arrhythmia recurrence on any type of recording (30 sec by TTM (event monitor), holters, 12-lead ECGs, rhythm strip or other diagnostic ECG documentation), absence of use of class I or III AAD	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 38RC23.0147

Drug and device information, study documents

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