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
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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RECRUITING
NA
80 participants
INTERVENTIONAL
2024-10-09
2026-10-01
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* With 2 compared groups
BASIC_SCIENCE
NONE
Study Groups
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Pulmonary vein isolation by pulse field ablation
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.
Pulmonary vein isolation by cryoablation
Pulmonary vein isolation by cryoablation
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.
Pulmonary vein isolation by cryoablation
Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP230296
Identifier Type: -
Identifier Source: org_study_id
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