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

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ClinicalTrials.gov Identifier: NCT01660100
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
Centro Cardiologico Monzino
Catholic University of the Sacred Heart
Capital Medical University
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE August 8, 2012
Last Update Posted Date October 19, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
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 ]
"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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
Outcome of atrial fibrillation ablation after permenant 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 ]
"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.
Change History Complete list of historical versions of study NCT01660100 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2013)
  • 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 ]
    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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • Long-term outcome of atrial fibrillation ablation after permenant 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 ]
    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) ]
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2012)
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 ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
Official Title  ICMJE Freedom From Atrial Arrhythmia in Atrial Fibrillation Patients After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Pulmonary vein antrum isolation (PVAI)
    Pulmonary vein antrum isolation (PVAI)
    Intervention: Procedure: Pulmonary vein antrum isolation (PVAI)
  • Active Comparator: PVAI plus left atrial posterior wall (LAPW) isolation
    PVAI plus left atrial posterior wall (LAPW) isolation
    Intervention: Procedure: PVAI plus left atrial posterior wall (LAPW) isolation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 3, 2012)
400
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01660100
Other Study ID Numbers  ICMJE LIBERATION
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
Study Sponsor  ICMJE Texas Cardiac Arrhythmia Research Foundation
Collaborators  ICMJE
  • Centro Cardiologico Monzino
  • Catholic University of the Sacred Heart
  • Capital Medical University
Investigators  ICMJE
Principal Investigator: 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
PRS Account Texas Cardiac Arrhythmia Research Foundation
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP