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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein antrum isolation (PVAI); Procedure: PVAI plus left atrial posterior wall (LAPW) isolation

• Registration Number: NCT01660100
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulmonary vein antrum isolation (PVAI)	Pulmonary vein antrum isolation (PVAI)	Pulmonary vein antrum isolation (PVAI)
PVAI plus left atrial posterior wall (LAPW) isolation	PVAI plus left atrial posterior wall (LAPW) isolation	PVAI plus left atrial posterior wall (LAPW) isolation

Primary Outcome Measures

Name	Time	Method
Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation	12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure	"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.

Secondary Outcome Measures

Name	Time	Method
Long-term outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation	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	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.
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)

Trial Locations

Locations (1)

Texas Cardiac Arrhythmia Institute; 🇺🇸 Austin, Texas, United States