The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation

NCT ID: NCT06557876

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-10-01

Brief Summary

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The goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. The main question it aims to answer is:

• Is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ?

Participants will performed 2 IRMs with injection and completed Quality of Life Questionnaires. They participate in the study for 4 months.

Researchers will compare 2 arms:

* Pulse-Field Ablation
* Cryoablation

Detailed Description

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Conditions

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Atrial Fibrillation Paroxysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* Interventional, single center, prospective, comparative, randomized (ratio of 1:1), open-label study.
* With 2 compared groups
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pulmonary vein isolation by pulse field ablation

Group Type ACTIVE_COMPARATOR

Pulmonary vein isolation by pulse field ablation

Intervention Type PROCEDURE

Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.

Pulmonary vein isolation by cryoablation

Group Type ACTIVE_COMPARATOR

Pulmonary vein isolation by cryoablation

Intervention Type PROCEDURE

Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.

Interventions

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Pulmonary vein isolation by pulse field ablation

Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.

Intervention Type PROCEDURE

Pulmonary vein isolation by cryoablation

Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient age ≥ 18
* Established diagnosis of paroxysmal fibrillation, with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
* Episode of AF documented by ECG within the last 12 months
* Patient able to give written informed consent
* If female of childbearing potential, have a negative serum pregnancy test and using effective contraception
* Be affiliated with a French social security system or entitled

Exclusion Criteria

* Non-paroxysmal atrial fibrillation
* Contraindication to oral anticoagulation
* Intracardiac thrombus
* Previous ablation in the left atrium
* Previous heart surgery
* Significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis
* Contraindication to perform MRI or using the DOTAREM™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with GFR \< 30 mL/min, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia)
* Patient on AME (state medical aid)
* Pregnant or breast-feeding female
* Patient protected by law (guardianship, tutelage measure, deprived of liberty)
* Participation in another interventional study or being in the exclusion period at the end of a previous study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marine CAMUS

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Dr Mikael Laredo

Paris, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mikael Laredo, MD, PhD

Role: CONTACT

+33184827620

Facility Contacts

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LAREDO

Role: primary

+33184827620

Other Identifiers

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APHP230296

Identifier Type: -

Identifier Source: org_study_id

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