Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06557876

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-15

80

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 18 years or older
  • Established diagnosis of paroxysmal atrial fibrillation with I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
  • Episode of atrial fibrillation documented by ECG within the last 12 months
  • Ability to provide written informed consent
  • If female of childbearing potential, negative serum pregnancy test and use of effective contraception
  • Affiliation with French social security system or entitlement
Not Eligible

You will not qualify if you...

  • Non-paroxysmal atrial fibrillation
  • Contraindication to oral anticoagulation
  • Presence of intracardiac thrombus
  • Previous ablation in the left atrium
  • Previous heart surgery
  • Significant valvular heart disease (moderate or severe mitral, aortic, or tricuspid valve disease)
  • Contraindication to MRI or use of DOTAREM194 contrast (including pacemaker, defibrillator, certain prostheses, severe kidney disease, hypersensitivity to gadoteric acid, severe claustrophobia)
  • Patient receiving state medical aid (AME)
  • Pregnant or breastfeeding female
  • Legal protection such as guardianship or deprived of liberty
  • Participation in another interventional study or within exclusion period after a previous study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dr Mikael Laredo

Paris, France, France, 75013

Actively Recruiting

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Research Team

M

Mikael Laredo, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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