Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation

NCT05940597 | Active Not Recruiting DMC

• 1 other identifier: 38RC23.0147
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation Paroxysmal

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (10)

• Health-related quality of life

  6 and 12 months

• Improvement in AF-specific quality of life

  6 and 12 months

• Proportion of patients with death

  12 months

• Proportion of patients with first hospitalization for cardiovascular causes.

  12 months

• Proportion of patients with acute complication related to the procedure

  during the procedure or one day after

Study Arms (2)

Cryoablation arm

ACTIVE COMPARATOR

Market approved cryoablation system

Device: Cryoballoon pulmonary vein isolation

PFA arm

EXPERIMENTAL

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

Device: Pulse field ablation

Interventions

Pulse field ablation DEVICE

ablation of paroxysmal atrial fibrillation by Pulse field ablation

PFA arm

Cryoballoon pulmonary vein isolation DEVICE

ablation of paroxysmal atrial fibrillation by Cryoballoon pulmonary vein isolation

Cryoablation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 under administrative or judicial supervision

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

FR (1)