RecruitingNot ApplicableNCT06557876

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

80 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of catheter ablation — a procedure where a thin tube is inserted into the heart to destroy abnormal electrical tissue causing an irregular heartbeat — for paroxysmal atrial fibrillation (AF that comes and goes). It compares traditional thermal ablation to a newer method called pulse field ablation, focusing on how each affects heart muscle function. **You may be eligible if...** - You are 18 or older with paroxysmal atrial fibrillation - Your doctor has recommended catheter ablation as treatment - You have had an ECG-documented AF episode in the last 12 months - You are affiliated with the French social security system **You may NOT be eligible if...** - Your atrial fibrillation is persistent (ongoing), not episodic - You cannot take blood thinners (anticoagulation) - You have a blood clot in your heart - You have had prior ablation or heart surgery on the left side of the heart - You have significant valve disease - You have an implanted device incompatible with MRI (e.g., pacemaker, cochlear implant) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPulmonary 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.

PROCEDUREPulmonary vein isolation by cryoablation

Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.


Locations(1)

Dr Mikael Laredo

Paris, France, France

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NCT06557876


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