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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 14, 2024

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ClinConnect Summary

This clinical trial is exploring how different types of energy used in catheter ablation can affect heart function in patients with a specific type of irregular heartbeat called paroxysmal atrial fibrillation. The two techniques being compared are pulse-field ablation and cryoablation. The main goal is to find out if pulse-field ablation helps maintain better heart function compared to the traditional method of cryoablation.

To participate in this study, you must be at least 18 years old and have a diagnosis of paroxysmal atrial fibrillation. Participants will undergo two MRI scans and fill out quality of life questionnaires over a 4-month period. It's important to note that certain conditions, such as having a history of heart surgery or specific heart valve problems, may exclude you from the study. If you qualify, you’ll be contributing to valuable research that could improve treatment options for atrial fibrillation.

Gender

ALL

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.