Comparing pulse field ablation and cryoablation for atrial fibrillation treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of two different catheter ablation techniques, pulse field ablation and cryoablation, on atrial function in patients with paroxysmal atrial fibrillation. Participants aged 18 and older will undergo pulmonary vein isolation using either method, with their atrial mechanics assessed through MRI and quality of life questionnaires over a four-month period. The primary objective is to determine whether pulse field ablation better preserves atrial function compared to cryoablation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dr Mikael Laredo
  Paris, France, France Recruiting

Study contacts

• Study coordinator: Mikael Laredo, MD, PhD
• Email: mikael.laredo@aphp.fr
• Phone: +33184827620

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pulsed-field pulmonary vein isolation with optional radiofrequency nerve-targeting for paroxysmal atrial fibrillation

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• nano-second pulsed field (nsPFA) catheter ablation for paroxysmal atrial fibrillation using the CellFX system

  The study will try the CellFX nano-second pulsed field catheter to treat adults with recurrent, drug-resistant paroxysmal atrial fibrillation.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.