The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging

NCT07499531 | Not Yet Recruiting

• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessing the impact of a new atrial fibrillation (AF) catheter ablation energy on left atrial structure and function is of crucial importance. The goal of this clinical trial is to assess the effect of pulsed-field ablation of atrial fibrillation on left atrial structure.

Conditions

Persistant Atrial Fibrillation; Paroxysmal AF

Keywords

Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Difference between baseline (pre-ablation) and post-ablation (4 months) in the amount of left atrial fibrosis such as quantified by 3D late gadolinium enhancement (g, %) (MRI measurement).

  From baseline to 4 months post ablation

Secondary Outcomes (5)

• Difference between baseline (pre-ablation) and post-ablation (4 months) in global left atrial strain (%)

  From baseline to 4 months post ablation

• Difference between baseline (pre-ablation) and post-ablation (4 months) in regional left atrial strains (%)

  From baseline to 4 months post ablation

• Difference between baseline (pre-ablation) and post-ablation (4 months) LA adipose tissue, measured by CT (cm^2, mm^3, %)

  From baseline to 4 months post ablation

• Difference between baseline (pre-ablation) and post-ablation (4 months) left atrial flow assessed by 4D-flow MRI and quantified by velocity histograms (cm/s); vortices number, characterization (n) and duration (ms) ; LA stasis

  From baseline to 4 months post ablation

• Difference between baseline (pre-ablation) and post-ablation (4 months) in left atrial wall thickness (mm)

  From baseline to 4 months post ablation

Study Arms (1)

Atrial ablation including at least pulmonary vein isolation and posterior wall isolation

EXPERIMENTAL

The intervention under investigation is pulse-field ablation (PFA) which is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.

Procedure: Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation

Interventions

Atrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation PROCEDURE

Persistent or paroxysmal atrial fibrillation treated by pulse-field ablation. Interventions added by the study are cardiac MRI (pre-ablation and 4 months after ablation) with administration of contrast agent (Dotarem®).

Atrial ablation including at least pulmonary vein isolation and posterior wall isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 18
• Established diagnosis of persistent or paroxysmal atrial fibrillation with a I/IIa/IIb indication for catheter ablation (ESC 2020 guidelines)
• AF ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolation
• 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

You may not qualify if:

• Only pulmonary vein isolation is scheduled
• Atrial fibrillation present at ECG during the pre-ablation (V1a) visit
• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Houria Mebarek

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Mikael Laredo, MD, PhD

CONTACT

+33 1 84 82 76 20; mikael.laredo@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03