Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07499531

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
39 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAtrial fibrillation ablation procedure planned using pulsed-field ablation and including at least pulmonary vein isolation and posterior wall isolationPersistent 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®).

Timeline

Start date
2026-04-01
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2026-03-30
Last updated
2026-03-30

Source: ClinicalTrials.gov record NCT07499531. Inclusion in this directory is not an endorsement.