Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
NCT ID: NCT01660100
Last Updated: 2017-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
400 participants
INTERVENTIONAL
2012-07-31
2016-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pulmonary vein antrum isolation (PVAI)
Pulmonary vein antrum isolation (PVAI)
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.
PVAI plus left atrial posterior wall (LAPW) isolation
PVAI plus left atrial posterior wall (LAPW) isolation
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
2. AF patient undergoing primary catheter ablation (first procedure)
3. Ability to give informed consent
Exclusion Criteria
2. Bleeding disorder
3. Reversible causes of AF, such as hyperthyroidism and phaeochromocytoma
18 Years
ALL
No
Sponsors
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Centro Cardiologico Monzino
OTHER
Catholic University of the Sacred Heart
OTHER
Capital Medical University
OTHER
Texas Cardiac Arrhythmia Research Foundation
OTHER
Responsible Party
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Andrea Natale
Executive Medical Director
Principal Investigators
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Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Insititute
Luigi Di Biase, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia Insititute
Claudio Tondo, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiologico Monzino
Rong Bai, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Texas Cardiac Arrhythmia Institute
Austin, Texas, United States
Countries
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References
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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.
Other Identifiers
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LIBERATION
Identifier Type: -
Identifier Source: org_study_id