Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial (LEAP-AF)

Institute for Clinical Effectiveness, Japan

Status and phase: Active, not recruiting; Phase 4

Conditions: Posterior Wall Isolation; Pulmonary Vein Isolation; Persistent Atrial Fibrillation; Catheter Ablation

Treatments: Procedure: Pulmonary vein isolation; Procedure: Left posterior wall isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT04405258

947

Details and patient eligibility

About

The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Full description

PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for first catheter ablation of persistent atrial fibrillation
• Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration
• Patients with persisting duration of atrial fibrillation less than 3 years
• Patients with left atrial diameter less than 50mm
• Patients who can be followed up for 18 months
• Patients with written informed consent

Exclusion criteria

• Patients who can not be received adequate anticoagulation therapy
• Patients with history of myocardial infarction within 6 months
• Patients with history of open heart surgery
• Patients scheduled for open heart surgery
• Patients with severe valvular heart disease
• Patients during pregnancy
• Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease
• Patients considered unsuitable for study by the attending physician

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

PVI alone

Active Comparator group

Description:

Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation

Treatment:

Procedure: Pulmonary vein isolation

PVI and PWI

Active Comparator group

Description:

Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation

Treatment:

Procedure: Left posterior wall isolation