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NCT Number: NCT06557876

The Effect of Pulse Field Ablation on Atrial Mechanics in Catheter Ablation of Paroxysmal Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Paroxysmal Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary vein isolation by pulse field ablation

Procedure

Pulse Field Ablation (PFA) is a non-thermal energy based on high voltage, ultra-short energy pulses applied selectively to cardiomyocytes.

Pulmonary vein isolation by cryoablation

Procedure

Cryoablation is a conventional thermal energy, also delivered with a single-shot cryoballoon device.

Primary outcomes

  1. 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)

    Time frame: 3 months

Secondary outcomes

  1. Difference between baseline (pre-ablation) and post-ablation in global left atrial strain (%) (related to secondary objective 1) (MRI measurement)

    Time frame: 3 months

  2. Difference between baseline (pre-ablation) and post-ablation in regional left atrial strains (%) (related to secondary objective 1) (MRI measurement)

    Time frame: 3 months

  3. 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)

    Time frame: 3 months

  4. Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by 4D-flow MRI (related to secondary objective 3) (MRI measurement)

    Time frame: 3 months

  5. Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by vortices number (related to secondary objective 3) (MRI measurement)

    Time frame: 3 months

  6. Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by characterization (n) (related to secondary objective 3) (MRI measurement)

    Time frame: 3 months

  7. Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by duration (ms) (related to secondary objective 3) (MRI measurement)

    Time frame: 3 months

  8. Difference between baseline (pre-ablation) and post-ablation left atrial flow assessed by LA stasis (related to secondary objective 3) (MRI measurement)

    Time frame: 3 months

  9. Heart rate measured the day after ablation and 3 months after (related to secondary objective 4)

    Time frame: 3 months

  10. 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.

    Time frame: 0 day

  11. 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.

    Time frame: 15 days

  12. 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.

    Time frame: 0 day

  13. 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.

    Time frame: 15 days

  14. Numeric rating pain scale (NRS) (0-10) measured 24 hours after ablation (related to secondary objective 4)

    Time frame: 1 day

  15. Numeric rating pain scale (NRS) (0-10) measured 15 days after ablation (related to secondary objective 4)

    Time frame: 15 days

Study contacts

Contact information is provided by the study sponsor or research team.

Mikael Laredo, MD, PhD

CONTACT

[email protected]

+33184827620

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: PF-MRI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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