Health TrialsbyHealthPanel

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

ConditionsPersistant Atrial FibrillationParoxysmal AF
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Only pulmonary vein isolation is scheduled

Atrial fibrillation present at ECG during the pre-ablation (V1a) visit

Contraindication to oral anticoagulation

Intracardiac thrombus

Trial design

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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®).

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Atrial ablation including at least pulmonary vein isolation and posterior wall isolationExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
From baseline to 4 months post ablation

Secondary outcomes

1

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

Time frame
From baseline to 4 months post ablation
2

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

Time frame
From baseline to 4 months post ablation
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: