Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF

NCT ID: NCT06633523

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-01-01

Brief Summary

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).

Detailed 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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary Vein Isolation (PVI) alone

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

PVI + Posterior Wall Isolation (PWI)

Intervention Type: PROCEDURE

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.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Pulmonary Vein Isolation (PVI) alone

Intervention Type: PROCEDURE

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.

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

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.

Group Type: EXPERIMENTAL

PVI + Posterior Wall Isolation (PWI)

Intervention Type: PROCEDURE

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.

Pulmonary Vein Isolation (PVI) alone

Intervention Type: PROCEDURE

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.

Interventions

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

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

Intervention Type: PROCEDURE

PVI + Posterior Wall Isolation (PWI)

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.

Intervention Type: PROCEDURE

Pulmonary Vein Isolation (PVI) alone

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital affiliated to Tongji University

UNKNOWN

Sponsor Role: collaborator

Shanghai 10th People's Hospital

UNKNOWN

Sponsor Role: collaborator

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xumin Hou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Central Contacts

Mu Qin, Doctor

Role: CONTACT

qinmuae@163.com

+8613052320103

Other Identifiers

OPLAWAS-AF

Identifier Type: -

Identifier Source: org_study_id