Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation

Texas Cardiac Arrhythmia Research Foundation

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: PVAI plus left atrial posterior wall (LAPW) isolation; Procedure: Pulmonary vein antrum isolation (PVAI)

Study type: Interventional

Funder types: Other

Identifiers

NCT01660100

LIBERATION

Details and patient eligibility

About

Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF).

Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years
2. AF patient undergoing primary catheter ablation (first procedure)
3. Ability to give informed consent

Exclusion criteria

1. Previous ablation of AF
2. Bleeding disorder
3. Reversible causes of AF, such as hyperthyroidism and phaeochromocytoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Pulmonary vein antrum isolation (PVAI)

Active Comparator group

Description:

Pulmonary vein antrum isolation (PVAI)

Treatment:

Procedure: Pulmonary vein antrum isolation (PVAI)

PVAI plus left atrial posterior wall (LAPW) isolation

Active Comparator group

Description:

PVAI plus left atrial posterior wall (LAPW) isolation

Treatment:

Procedure: PVAI plus left atrial posterior wall (LAPW) isolation