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

Primary Purpose

Atrial Fibrillation Paroxysmal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulse field ablation
Cryoballoon pulmonary vein isolation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation Paroxysmal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Cryoablation arm

    PFA arm

    Arm Description

    Market approved cryoablation system

    Market approved PFA ablation system (Farapulse - Boston Scientific system).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Health-related quality of life
    SF-12 questionnaire.
    Improvement in AF-specific quality of life
    AFEQT questionnaire
    Proportion of patients with death
    Death from any causes
    Proportion of patients with first hospitalization for cardiovascular causes.
    First hospitalization for cardiovascular causes
    Proportion of patients with acute complication related to the procedure
    tamponade, stroke, myocardial infarction, other
    Total procedure duration
    Procedure duration in minutes
    Total time of fluoroscopy
    Total time of fluoroscopy in minutes
    Proportion of patients with embolic events from arrhythmia
    Stroke
    Long term complications related to the procedure
    phrenic palsy, pulmonary vein stenosis, pericarditis, other
    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

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 4, 2023
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05940597
    Brief Title
    Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
    Acronym
    FACIL AF
    Official Title
    Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Paroxysmal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cryoablation arm
    Arm Type
    Active Comparator
    Arm Description
    Market approved cryoablation system
    Arm Title
    PFA arm
    Arm Type
    Experimental
    Arm Description
    Market approved PFA ablation system (Farapulse - Boston Scientific system).
    Intervention Type
    Device
    Intervention Name(s)
    Pulse field ablation
    Intervention Description
    ablation of paroxysmal atrial fibrillation by Pulse field ablation
    Intervention Type
    Device
    Intervention Name(s)
    Cryoballoon pulmonary vein isolation
    Intervention Description
    ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation
    Primary Outcome Measure Information:
    Title
    proportion of subjects experiencing one-year single-procedure clinical success
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Health-related quality of life
    Description
    SF-12 questionnaire.
    Time Frame
    6 and 12 months
    Title
    Improvement in AF-specific quality of life
    Description
    AFEQT questionnaire
    Time Frame
    6 and 12 months
    Title
    Proportion of patients with death
    Description
    Death from any causes
    Time Frame
    12 months
    Title
    Proportion of patients with first hospitalization for cardiovascular causes.
    Description
    First hospitalization for cardiovascular causes
    Time Frame
    12 months
    Title
    Proportion of patients with acute complication related to the procedure
    Description
    tamponade, stroke, myocardial infarction, other
    Time Frame
    during the procedure or one day after
    Title
    Total procedure duration
    Description
    Procedure duration in minutes
    Time Frame
    during the procedure
    Title
    Total time of fluoroscopy
    Description
    Total time of fluoroscopy in minutes
    Time Frame
    during the procedure
    Title
    Proportion of patients with embolic events from arrhythmia
    Description
    Stroke
    Time Frame
    12 months
    Title
    Long term complications related to the procedure
    Description
    phrenic palsy, pulmonary vein stenosis, pericarditis, other
    Time Frame
    12 months
    Title
    Recurrence of atrial fibrillation
    Description
    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
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandrine VENIER
    Phone
    +334767688888
    Email
    svenier@chu-grenoble.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah LIMON
    Email
    slimon@chu-grenoble.fr

    12. IPD Sharing Statement

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    Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation

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