Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatments pulmonary vein antrum isolation (pvai), pvai plus left atrial posterior wall (lapw) isolation
Sponsor Texas Cardiac Arrhythmia Research Foundation
Collaborator Centro Cardiologico Monzino
Start date July 2012
End date December 2016
Trial size 400 participants
Trial identifier NCT01660100, LIBERATION

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Pulmonary vein antrum isolation (PVAI)
pulmonary vein antrum isolation (pvai)
In this group, only standard PVAI will be performed during the primary procedure. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum remains isolated will enter follow-up; however, patients who have pulmonary vein-left atrium reconnection will undergo an re-isolation. Patients who have pulmonary vein antrum re-isolation are subject to a 3rd procedure 3 months later to check the status of pulmonary vein-left atrium connection. Patients will enter follow-up for long-term outcome only after permanent PVAI is confirmed by a repeat procedure.
(Active Comparator)
PVAI plus left atrial posterior wall (LAPW) isolation
pvai plus left atrial posterior wall (lapw) isolation
In this group, PVAI will be extended to the entire LAPW to achieve LAPW isolation during the primary ablation. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum and LAPW remain isolated will enter follow-up; however, patients who have pulmonary vein antrum and/or LAPW reconnection will undergo a re-isolation. Patients who have pulmonary vein antrum and/or LAPW re-isolation are subject to a 3rd procedure three month later to check the presence of pulmonary vein antrum and/or LAPW re-connection. Patients will enter follow-up for long-term outcome only after PVAI and LAPW isolation are proven by a repeat procedure.

Primary Outcomes

Measure
Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation
time frame: 12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure

Secondary Outcomes

Measure
Long-term outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation
time frame: 24 and 36 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure
Quality of life after atrial fibrillation ablation
time frame: Before atrial fibrillation ablation and 3, 6, 12 months after normal sinus rhythm is restored by successful ablation(s)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Freedom From Atrial Arrhythmia in Atrial Fibrillation Patients After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
Principal investigator Andrea Natale, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation.