Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF

NCT06633523 | Not Yet Recruiting

• 1 other identifier: OPLAWAS-AF
• Study Type: interventional
• Target: 384
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Persistent Atrial Fibrillation

Keywords

pulmonary vein isolation; pulse field ablation; anatomical and potential-guided ablation; posterior left atrial wall ablation

Outcome Measures

Primary Outcomes (1)

• recurrence of atrial arrhythmias

  Following a single ablation procedure, after discontinuation of antiarrhythmic drugs, there should be at least 12 months of follow-up without any documented episodes of atrial arrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\], or atrial flutter \[AFL\]) lasting more than 30 seconds, outside the initial 3-month blanking period.

  at least 12 months of follow-up, beyond the initial 3-month blanking period

Secondary Outcomes (17)

• no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• occurrence of any documented atrial arrhythmia lasting more than 30 seconds

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• the burden of atrial fibrillation at 12 months of follow-up between different study groups

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• no occurrence of any documented atrial arrhythmia lasting more than 30 seconds

  at least 12 months of follow-up, beyond the initial 3-month blanking period

• no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days

  at least 12 months of follow-up, beyond the initial 3-month blanking period

Study Arms (3)

Pulmonary Vein Isolation (PVI) alone

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

Procedure: PVI + Posterior Wall Isolation (PWI); Procedure: Pulmonary Vein Isolation (PVI) alone

Interventions

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

PVI + Posterior Wall Isolation (PWI) 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.

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Tongji Hospital affiliated to Tongji University: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Single Person

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Xumin Hou, Doctor

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu Qin, Doctor

CONTACT

+8613052320103; qinmuae@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 9, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10