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NCT05940597Completed

Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
354 (actual)
First submitted
4 Jul 2023
Start date
25 Sept 2023
Primary completion date
23 Mar 2026
Lead sponsor
University Hospital, Grenoble
NCT number
NCT05940597

What you commit to

  • Study type: Interventional
  • Participants enrolled: 354
  • From 25 Sept 2023 to the primary completion date, 23 Mar 2026
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous AF ablation

Other illness

  • The patient is contraindicated or allergic to oral anticoagulation

Other

  • Persistent and permanent AF
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Caen Normandie
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CaenFranceUnknown status
CHU Grenoble Alpes
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GrenobleFranceUnknown status
CHU Montpellier
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MontpellierFranceUnknown status
Aphp Hegp
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ParisFranceUnknown status
CHU Rouen
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RouenFranceUnknown status
Clinique Pasteur
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ToulouseFranceUnknown status
CHRU Tours
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ToursFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.