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NCT Number: NCT05940597

Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Grenoble Alpes

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse Field Ablation

Device

ablation of paroxysmal atrial fibrillation by Pulse field ablation

Cryoballoon pulmonary vein isolation

Device

ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation

Primary outcomes

  1. proportion of subjects experiencing one-year single-procedure clinical success

    Time frame: 12 months

    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.

Secondary outcomes

  1. Health-related quality of life

    Time frame: 6 and 12 months

    SF-12 questionnaire.

  2. Improvement in AF-specific quality of life

    Time frame: 6 and 12 months

    AFEQT questionnaire

  3. Proportion of patients with death

    Time frame: 12 months

    Death from any causes

  4. Proportion of patients with first hospitalization for cardiovascular causes.

    Time frame: 12 months

    First hospitalization for cardiovascular causes

  5. Proportion of patients with acute complication related to the procedure

    Time frame: during the procedure or one day after

    tamponade, stroke, myocardial infarction, other

  6. Total procedure duration

    Time frame: during the procedure

    Procedure duration in minutes

  7. Total time of fluoroscopy

    Time frame: during the procedure

    Total time of fluoroscopy in minutes

  8. Proportion of patients with embolic events from arrhythmia

    Time frame: 12 months

    Stroke

  9. Long term complications related to the procedure

    Time frame: 12 months

    phrenic palsy, pulmonary vein stenosis, pericarditis, other

  10. Recurrence of atrial fibrillation

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: FACIL AF

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2023
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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