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

NCT06557876 | Recruiting

• 1 other identifier: APHP230296
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation Paroxysmal

Outcome Measures

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)

  3 months

Secondary Outcomes (15)

• 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

• 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

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

  3 months

Study Arms (2)

Pulmonary vein isolation by pulse field ablation

ACTIVE COMPARATOR

Procedure: Pulmonary vein isolation by pulse field ablation

Pulmonary vein isolation by cryoablation

ACTIVE COMPARATOR

Procedure: Pulmonary vein isolation by cryoablation

Interventions

Pulmonary vein isolation by cryoablation PROCEDURE

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

Pulmonary vein isolation by cryoablation

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 pulse field ablation

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 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Dr Mikael Laredo

Paris, France, 75013, France

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Marine CAMUS

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Mikael Laredo, MD, PhD

CONTACT

+33184827620; mikael.laredo@aphp.fr

Study Design

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

Model Details: * Interventional, single center, prospective, comparative, randomized (ratio of 1:1), open-label study. * With 2 compared groups

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)