Clinical trial NCT05940597: Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
Official title: Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: proportion of subjects experiencing one-year single-procedure clinical success
timeFrame: 12 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 6 and 12 months
measure: Improvement in AF-specific quality of life
timeFrame: 6 and 12 months
measure: Proportion of patients with death
timeFrame: 12 months
measure: Proportion of patients with first hospitalization for cardiovascular causes.
timeFrame: 12 months
measure: Proportion of patients with acute complication related to the procedure
timeFrame: during the procedure or one day after
measure: Total procedure duration
timeFrame: during the procedure
measure: Total time of fluoroscopy
timeFrame: during the procedure
measure: Proportion of patients with embolic events from arrhythmia
timeFrame: 12 months
measure: Long term complications related to the procedure
timeFrame: 12 months
measure: Recurrence of atrial fibrillation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: