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.

Verified January 2013 by Texas Cardiac Arrhythmia Research Foundation

Sponsor:

Collaborators:

Centro Cardiologico Monzino, IRCCS, Milan, Italy

Catholic University of the Sacred Heart

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

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: January 21, 2013

Last verified: January 2013

History of Changes

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

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 2013 (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.

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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Beijing Anzhen Hospital, Capital Medical University, Beijing, China

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, Capital Medical University, Beijing, China

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:	January 21, 2013
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 June 18, 2013

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