Comparing pulse field ablation and cryoablation for atrial fibrillation treatment

The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation

This study is testing whether a new method called pulse field ablation works better than the traditional cryoablation for treating atrial fibrillation and keeping the heart's function healthy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris, France)
• Trial ID: NCT06557876 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of paroxysmal atrial fibrillation who meet specific inclusion criteria.

Not a fit: Patients with non-paroxysmal atrial fibrillation or significant heart conditions that contraindicate the procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with paroxysmal atrial fibrillation, enhancing their heart function and quality of life.

How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in improving atrial function with different ablation techniques, making this a relevant area of investigation.

Eligibility criteria

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 this trial is running

Paris, France

• Dr Mikael Laredo — Paris, France, France (Recruiting)

Study contacts

• Study coordinator: Mikael Laredo, MD, PhD

Conditions Atrial Fibrillation Paroxysmal