The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
NCT Number: NCT06557876
Acronym: PF-MRI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation Paroxysmal
Interventions: PROCEDURE: Pulmonary vein isolation by pulse field ablation|PROCEDURE: Pulmonary vein isolation by cryoablation
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09-01
Completion Date: 2026-02-01

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

Primary Outcome Measures: Difference between baseline (pre-ablation) and post-ablation in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (related to primary objective) (MRI measurement), 3 months
Secondary Outcome Measures: Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation LA adipose tissue, measured by CT (cm2, mm3, %) (related to secondary objective 1 and 2) (CT measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement), 3 months|Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement), 3 months|Heart rate measured the day after ablation and 3 months after (related to secondary objective 4), 3 months|SF-36 (Short-Form-36) Physical Health Composite questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result., 0 day|SF-36 (Short-Form-36) Physical Health Composite questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 800; a higher score means a better result., 15 days|Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured before ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result., 0 day|Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaires measured 15 days after ablation (related to secondary objective 4). The minimum value is 0 and the maximum is 100; a higher score means a better result., 15 days|Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4), 1 day|Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4), 15 days