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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Texas Cardiac Arrhythmia Research Foundation
Sponsor:
Collaborators:
Centro Cardiologico Monzino, IRCCS, Milan, Italy
Catholic University of the Sacred Heart
Capital Medical University
Tong-Ji Hospital, Tong-Ji Medical College, HUST, Wuhan, China
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier:
NCT01660100
First received: August 1, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Procedure: Pulmonary vein antrum isolation (PVAI)
Procedure: PVAI plus left atrial posterior wall (LAPW) isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Texas Cardiac Arrhythmia Research Foundation:

Primary Outcome Measures:
  • Outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation [ Time Frame: 12 months after pulmonary vein antrum isolation or pulmonary vein antrum plus left atrial posterior wall isolation is proven by a repeat procedure ] [ Designated as safety issue: No ]

    "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:
  • Long-term outcome of atrial fibrillation ablation after permanent pulmonary vein antrum isolation or proven pulmonary vein antrum plus left atrial posterior wall isolation [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before atrial fibrillation ablation and 3, 6, 12 months after normal sinus rhythm is restored by successful ablation(s) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Freedom from atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) after non-pulmonary vein trigger ablation [ Time Frame: 6 and 12 months after re-do ablation in previously "failed" patients ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pulmonary vein antrum isolation (PVAI)
Pulmonary vein antrum isolation (PVAI)
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.
Active Comparator: PVAI plus left atrial posterior wall (LAPW) isolation
PVAI plus left atrial posterior wall (LAPW) isolation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660100

Contacts
Contact: Rong Bai, MD 5125448197 bairong74@gmail.com
Contact: Luigi Di Biase, MD, PhD 5125448196 dibbia@gmail.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Institute Recruiting
Austin, Texas, United States, 78705
Contact: Mitra Mohanty    512-544-8198    Mitra.Mohanty@stdavids.com   
Contact: Deb Cardinal    512-458-9410    dscsrdinal@austinheartbeat.com   
Sponsors and Collaborators
Texas Cardiac Arrhythmia Research Foundation
Centro Cardiologico Monzino, IRCCS, Milan, Italy
Catholic University of the Sacred Heart
Capital Medical University
Tong-Ji Hospital, Tong-Ji Medical College, HUST, Wuhan, China
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Insititute
Principal Investigator: Rong Bai, MD Tong-Ji Hospital, Wuhan, China
Principal Investigator: Luigi Di Biase, MD, PhD Texas Cardiac Arrhythmia Insititute
Principal Investigator: Claudio Tondo, MD Centro Cardiologico Monzino, IRCCS, Milan, Italy
Principal Investigator: Rong Bai, MD Beijing Anzhen Hospital
  More Information

No publications provided

Responsible Party: Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research Foundation
ClinicalTrials.gov Identifier: NCT01660100     History of Changes
Other Study ID Numbers: LIBERATION
Study First Received: August 1, 2012
Last Updated: April 14, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Texas Cardiac Arrhythmia Research Foundation:
Atrial fibrillation ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014