The Effect of Pulse Field Ablation of Atrial Fibrillation Involving Posterior Wall Ablation on Atrial Mechancis Assessed by Cardiac Magnetic Resonance Imaging (PF-MRI+)

March 24, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Until recently, pulmonary vein ablation was performed using thermal energy; Pulmonary vein ablation (PVA) is the cornerstone of catheter ablation techniques for the treatment of atrial fibrillation (AF). In paroxysmal atrial fibrillation (PAF), PVI achieves a high rate of sustained freedom from AF recurrence, due to the predominant role of AF triggers, primarily represented by the pulmonary veins (PVs). Until recently, two main ablation energies were used to perform PVI: radiofrequency (RF) and cryoablation, both of which rely on thermal injury to the atrial cardiomyocytes surrounding the pulmonary vein ostia. Thermal lesions are associated with coagulative necrosis, oedema, and macro- and microvascular damage. Over time, thermal ablation lesions are replaced by interstitial fibrosis, a non-contractile and inflexible tissue. It has been demonstrated that extensive ablation lesions in the left atrium (LA) exacerbate atrial cardiomyopathy by impairing the LA's reservoir function, which can lead to stiff left atrium syndrome. Furthermore, thermal ablation lesions have been associated with an increased risk of stroke, particularly in patients with a low fibrosis burden in the LA.

Pulsed-field ablation of atrial fibrillation, including ablation of the posterior wall, is associated with the absence of left atrial fibrosis or fatty metaplasia, as well as the preservation of left atrial mechanics and blood flow.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Participation in another interventional study or being in the exclusion period at the end of a previous study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atrial ablation including at least pulmonary vein isolation and posterior wall isolation
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
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®).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: From baseline to 4 months post ablation
From baseline to 4 months post ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between baseline (pre-ablation) and post-ablation (4 months) in global left atrial strain (%)
Time Frame: From baseline to 4 months post ablation
From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in regional left atrial strains (%)
Time Frame: From baseline to 4 months post ablation
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, %)
Time Frame: From baseline to 4 months post ablation
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
Time Frame: From baseline to 4 months post ablation
From baseline to 4 months post ablation
Difference between baseline (pre-ablation) and post-ablation (4 months) in left atrial wall thickness (mm)
Time Frame: From baseline to 4 months post ablation
From baseline to 4 months post ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Houria Mebarek, Assistance Publique - Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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