Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: PVI + Posterior Wall Isolation (PWI); Procedure: Pulmonary Vein Isolation (PVI) alone; Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06633523

OPLAWAS-AF

Details and patient eligibility

About

This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).

Full description

This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).

The main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (PVI) alone, PVI plus pulse field ablation (PWI), and PVI plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. The study is designed with three groups: the PVI-alone group, the PVI + PWI group, and the PVI plus anatomical and potential-guided ablation group.

Enrollment: 384 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients aged ≥18 years.
• Patients undergoing their first ablation procedure for PsAF.
• Persistent atrial fibrillation (AF): Defined as episodes lasting ≥7 days and ≤3 years (including those requiring pharmacological or electrical cardioversion ≥7 days).
• Atrial fibrillation symptoms that are intolerant to at least one antiarrhythmic drug (AAD).
• At least one episode of PsAF must have been documented within the last 2 years by methods such as ECG, Holter monitoring, loop recorder, telemetry, remote telemonitoring (TTM), or implanted devices prior to enrollment in this study.
• Patients must be capable and willing to provide written informed consent to participate in the study.
• Patients must be willing and able to comply with all study follow-up requirements.

Exclusion Criteria:

• Paroxysmal AF: Defined as episodes lasting <7 days (or resolved with medication/electrical cardioversion within <7 days).
• Patients with long-standing persistent AF: Defined as persistent AF lasting >3 years.
• Patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm.
• Contraindication to systemic anticoagulation.
• Pregnancy.
• Advanced renal or hepatic failure.
• Severe valvular heart disease or cyanotic congenital heart disease.
• Hypertrophic cardiomyopathy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 3 patient groups

Pulmonary Vein Isolation (PVI) alone

Experimental group

Description:

The distance between the ablation lines on the posterior wall after circumferential pulmonary vein isolation should be at least 2 centimeters to limit the portion of the posterior wall within the PVI ablation zone. PVI will be confirmed by verifying entrance and exit block at the PV orifices

Treatment:

Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)

Procedure: PVI + Posterior Wall Isolation (PWI)

Pulmonary Vein Isolation (PVI) + Posterior Wall Isolation (PWI)

Experimental group

Description:

After performing PVI, the mapping catheter will be placed on the posterior wall to assess electrical activity and guide ablation. A bottom linear ablation (25-40W) will be performed, connecting the lowest points beneath the lower PVs. A top linear ablation (25-40W) will be conducted at the top of the left atrium, connecting the highest points above the upper PVs. If posterior wall isolation is not achieved after completing the bottom and top lines, mapping and localization of the earliest activation point within the box will be performed during pacing from the coronary sinus (CS). Posterior wall isolation will be completed by identifying and ablating local potentials at the entry and exit sites.

Treatment:

Procedure: Pulmonary Vein Isolation (PVI) alone

Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)

PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)

Experimental group

Description:

After performing PVI, electrogram mapping of the posterior left atrial wall is conducted. Subsequently, PWI and EGM ablation are performed. In this group, multipolar mapping catheters are used for EGM mapping. Target EGMs include spatially discrete potentials (STPs), localized short cycle length potentials (SCLPs), and focal activities.

Treatment:

Procedure: Pulmonary Vein Isolation (PVI) alone

Procedure: PVI + Posterior Wall Isolation (PWI)