Chu Grenoble Alpes
Grenoble, 38043, France
NCT Number: NCT05940597
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Grenoble, 38043, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ablation of paroxysmal atrial fibrillation by Pulse field ablation
ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation
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.
Time frame: 6 and 12 months
SF-12 questionnaire.
Time frame: 6 and 12 months
AFEQT questionnaire
Time frame: 12 months
Death from any causes
Time frame: 12 months
First hospitalization for cardiovascular causes
Time frame: during the procedure or one day after
tamponade, stroke, myocardial infarction, other
Time frame: during the procedure
Procedure duration in minutes
Time frame: during the procedure
Total time of fluoroscopy in minutes
Time frame: 12 months
Stroke
Time frame: 12 months
phrenic palsy, pulmonary vein stenosis, pericarditis, other
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
University Hospital, Grenoble
Other
Acronym: FACIL AF
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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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