Clinical trial NCT01660100: Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation ablation
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: Catholic University of the Sacred Heart
name: Capital Medical University
First posted: 2012-08-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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
timeFrame: 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
timeFrame: 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
measure: Quality of life after atrial fibrillation ablation
timeFrame: Before atrial fibrillation ablation and 3, 6, 12 months after normal sinus rhythm is restored by successful ablation(s)
Other outcomes:
measure: Freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) after non-pulmonary vein trigger ablation
timeFrame: 6 and 12 months after re-do ablation in previously "failed" patients
Locations:
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Insititute
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Cardiac Arrhythmia Insititute
name: Luigi Di Biase, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Cardiologico Monzino
name: Claudio Tondo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital
name: Rong Bai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bai R, Di Biase L, Mohanty P, Trivedi C, Dello Russo A, Themistoclakis S, Casella M, Santarelli P, Fassini G, Santangeli P, Mohanty S, Rossillo A, Pelargonio G, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma CS, Tondo C, Natale A. Proven isolation of the pulmonary vein antrum with or without left atrial posterior wall isolation in patients with persistent atrial fibrillation. Heart Rhythm. 2016 Jan;13(1):132-40. doi: 10.1016/j.hrthm.2015.08.019. Epub 2015 Aug 13.