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

NCT01660100 | Completed

• 1 other identifier: LIBERATION
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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)

Other Outcomes (1)

• Freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) after non-pulmonary vein trigger ablation

  6 and 12 months after re-do ablation in previously "failed" patients

Study Arms (2)

Pulmonary vein antrum isolation (PVAI)

ACTIVE COMPARATOR

Pulmonary vein antrum isolation (PVAI)

Procedure: Pulmonary vein antrum isolation (PVAI)

PVAI plus left atrial posterior wall (LAPW) isolation

ACTIVE COMPARATOR

PVAI plus left atrial posterior wall (LAPW) isolation

Procedure: PVAI plus left atrial posterior wall (LAPW) isolation

Interventions

Pulmonary vein antrum isolation (PVAI) PROCEDURE

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.

Pulmonary vein antrum isolation (PVAI)

PVAI plus left atrial posterior wall (LAPW) isolation PROCEDURE

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.

PVAI plus left atrial posterior wall (LAPW) isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• AF patient undergoing primary catheter ablation (first procedure)
• Ability to give informed consent

You may not qualify if:

• Previous ablation of AF
• Bleeding disorder
• Reversible causes of AF, such as hyperthyroidism and phaeochromocytoma

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead
• Centro Cardiologico Monzino: collaborator
• Catholic University of the Sacred Heart: collaborator
• Capital Medical University: collaborator

Study Sites (1)

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

Location

Related Publications (1)

• 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.

  PMID: 26277862 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Insititute

  PRINCIPAL INVESTIGATOR

• Luigi Di Biase, MD, PhD

  Texas Cardiac Arrhythmia Insititute

  PRINCIPAL INVESTIGATOR

• Claudio Tondo, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

• Rong Bai, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 8, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

US (1)