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

ConditionAtrial Fibrillation Paroxysmal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non-paroxysmal atrial fibrillation

Contraindication to oral anticoagulation

Intracardiac thrombus

Previous ablation in the left atrium

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary vein isolation by pulse field ablation

    Procedure/Surgery

    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/Surgery

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Pulmonary vein isolation by pulse field ablationActive comparator 1 intervention
Group B: Pulmonary vein isolation by cryoablationActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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