NCT01660100

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

Freedom From Atrial Arrhythmia in Atrial Fibrillation Patients After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Texas Cardiac Arrhythmia Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-08-08
• Last updated: 2017-10-19

Locations

1 site across 1 country: United States