Actively Recruiting
The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-06-02
80
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different catheter ablation techniques on heart function in adults over 18 with paroxysmal atrial fibrillation. The study aims to determine whether pulse-field ablation better preserves the structure and function of the atrium compared to conventional cryoablation. This randomized clinical trial is sponsored by Assistance Publique - H f4pitaux de Paris and focuses on comparing these two energy methods during pulmonary vein isolation. Participants will be randomly assigned to receive either pulse-field ablation, which uses high voltage, ultra-short energy pulses to target heart cells without heat, or cryoablation, a traditional technique using freezing energy delivered by a cryoballoon device. The study involves two magnetic resonance imaging (MRI) scans with contrast to measure heart tissue changes and questionnaires to assess quality of life. The intervention and follow-up occur over a period of four months. During the study, participants undergo detailed heart imaging before and three months after ablation to measure changes in left atrial fibrosis and strain, blood flow characteristics, and fat tissue around the heart. Quality of life and pain levels are also assessed through standardized questionnaires and pain scales at multiple time points. Heart rate is monitored the day after ablation and at three months to evaluate recovery. The trial collects comprehensive data to compare the effects of the two ablation methods on heart function and patient outcomes.
CONDITIONS
Brief Title
The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient age 18 years
- Established diagnosis of paroxysmal atrial fibrillation with indication for catheter ablation
- Documented episode of atrial fibrillation by ECG within the last 12 months
- Ability to provide written informed consent
- If female of childbearing potential, negative pregnancy test and use of effective contraception
- Affiliated with French social security or entitled to it
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 moderate or severe valvular heart disease
- Contraindication to MRI or gadolinium contrast (e.g., pacemaker, severe kidney disease, allergy)
- Patient receiving state medical aid (AME)
- Pregnant or breastfeeding female
- Legally protected patients (guardianship, deprived of liberty)
- Participation in another interventional study or within exclusion period of a previous study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants undergo pulmonary vein isolation using either pulse field ablation or cryoablation to treat paroxysmal atrial fibrillation.
1 treatment visit (in-person)
Duration - 3 months
Participants are monitored to assess heart function, atrial mechanics, and patient-related outcomes after ablation.
Visits at 1 day, 15 days, and 3 months after ablation (in-person)
Trial Site Locations
Total: 1 location
1
Dr Mikael Laredo
Paris, France, France, 75013
Actively Recruiting
Research Team
M
Mikael Laredo, MD, PhD
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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