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

Assistance Publique - Hôpitaux de Paris1 个研究点分布在 1 个国家目标入组 80 人2024年10月9日

适应症Atrial Fibrillation Paroxysmal

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Atrial Fibrillation Paroxysmal
发起方: Assistance Publique - Hôpitaux de Paris
入组人数: 80
试验地点: 1
主要终点: 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)
状态: 招募中
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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

注册库

clinicaltrials.gov

开始日期

2024年10月9日

结束日期

2026年10月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Assistance Publique - Hôpitaux de Paris

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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)

结局指标

主要结局

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)

时间窗: 3 months

次要结局

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)
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)
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (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)
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)
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)
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)
Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement)(3 months)
Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4)(15 days)
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)
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)
Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4)(1 day)