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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660100
• Other study ID #: LIBERATION
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: October 17, 2017
• Start date: July 2012
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation	Capital Medical University, Catholic University of the Sacred Heart, Centro Cardiologico Monzino

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) after non-pulmonary vein trigger ablation	In patients who experience "procedure failure" (defined above), a re-do ablation may be performed. During the re-do procedure, in addition to re-isolation of re-connected pulmonary vein antrum and left atrial posterior wall, all non-pulmonary vein triggers will be eliminated. Then the patients will be followed-up again for atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) recurrence.	6 and 12 months after re-do ablation in previously "failed" patients
Primary	Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation	"Procedure success" is defined as freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven.; "Procedure failure" is defined as atrial arrhythmia recurrence during follow-up after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven.	12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure
Secondary	Long-term outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation	Patients who remain free from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) off antiarrhythmic drug at the 12th month will be continuously followed-up every 3 months. Outcome ("Procedure success" or "Procedure failure") of atrial fibrillation ablation will be assessed at the 24th and 36th month.	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
Secondary	Quality of life after atrial fibrillation ablation		Before atrial fibrillation ablation and 3, 6, 12 months after normal sinus rhythm is restored by successful ablation(s)