Clinical trial NCT06557876: The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation
Official title: The Effect of Pulse Field Ablation on Atrial Mechanics Assessed by MRI and on Patient-related Outcomes in Catheter Ablation of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation Paroxysmal
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Interventional, single center, prospective, comparative, randomized (ratio of 1:1), open-label study.
* With 2 compared groups
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Primary outcomes:
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement)
timeFrame: 3 months
measure: Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement)
timeFrame: 3 months
measure: Heart rate measured the day after ablation and 3 months after (related to secondary objective 4)
timeFrame: 3 months
measure: 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.
timeFrame: 0 day
measure: 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.
timeFrame: 15 days
measure: 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.
timeFrame: 0 day
measure: 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.
timeFrame: 15 days
measure: Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4)
timeFrame: 1 day
measure: Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4)
timeFrame: 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Dr Mikael Laredo
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marine CAMUS
role: STUDY_DIRECTOR
References: