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Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation (BELIEF)

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ClinicalTrials.gov Identifier: NCT01362738
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE May 30, 2011
Last Update Posted Date April 26, 2017
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
Freedom from AF/ATs [ Time Frame: 12 months ]
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting >30 seconds at follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
Severe adverse events due to cardiac cause [ Time Frame: 12 months ]
Severe adverse events (hospital admissions or death due to a cardiac cause)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation
Official Title  ICMJE Effect of Empirical Left Atrial Appendage Isolation on Long-term Procedure Outcome in Patients With Persistent or Long-standing Persistent Atrial Fibrillation Undergoing Catheter Ablation
Brief Summary The purpose of this prospective randomized study is to assess whether empirical Left Atrial Appendage (LAA) isolation along with the standard approach of pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers is superior to the standard approach alone in enhancing the long-term success rate of catheter ablation in persistent or long-standing persistent atrial fibrillation (AF) patients.
Detailed Description

Persistent (PeAF) and long-standing persistent (LSP) AF are defined as sustained AFs extending beyond seven days and one year respectively (1). Hypertensive, ischemic, valvular and other structural heart diseases most commonly underlie these arrhythmias (2) and the resulting abnormal atrial substrate is believed to be the major contributor toward perpetuation of AF in these non-paroxysmal categories. Several studies have demonstrated that pulmonary vein isolation (PVI) by radiofrequency catheter ablation (RFCA) though successfully restores sinus rhythm in most patients with paroxysmal AF; it has limited success in these sustained arrhythmias (3). Presence of potential trigger-generating areas in the left and right atrium besides pulmonary veins, with reported incidence from 3.2% to 47% (4), can be held responsible for this limited success. These areas include superior vena cava, ligament of Marshall, crista terminalis, coronary sinus, left atrial (LA) posterior wall and LA appendage (3). Therefore, in order to enhance the procedural-success rate, various hybrid measures have emerged to target the PV as well as extra-PV areas that have the ability to initiate or maintain AF. Several previous studies have demonstrated the prevalence of LAA firing in patients with recurrence of AF/AT (atrial tachycardia) after catheter ablation of AF (4). Embryologically, LAA is the remnant of primitive LA, which is formed by the adsorption of primordial PV and their branches during 4th week of embryonic development. Therefore, it is logical to suggest that LAA may initiate AF like pulmonary veins. In an earlier study conducted by our group on 987 AF patients, LAA firing was revealed to be the source of AF in 27% of patients and 93% of those patients were arrhythmia free 6 months after LAA isolation (4).

Our study aims to compare the procedure outcome for two different ablation strategies; 1) standard approach of pulmonary vein isolation extended to the posterior wall down to the coronary sinus and to the left side of the interatrial septum along with isolation of superior vena cava and ablation of complex fractionated atrial electrograms (CFAE) in the atria and coronary sinus, 2) standard approach plus LAA isolation.

Hypothesis: LAA isolation combined with standard ablation procedure enhances the procedural success rate in non-paroxysmal AF patients undergoing catheter ablation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE
  • Procedure: RFCA of PV and extra-PV triggers
    PVAI and isolation of extra PV triggers
  • Procedure: LAA isolation along with the conventional ablation strategy
    PVAI + isolation of extra PV triggers + LAA isolation
Study Arms  ICMJE
  • Active Comparator: Ablation of PV and extra-PV triggers
    Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers
    Intervention: Procedure: RFCA of PV and extra-PV triggers
  • Active Comparator: LAA isolation along with the conventional ablation strategy
    LAA isolation along with the conventional ablation strategy
    Intervention: Procedure: LAA isolation along with the conventional ablation strategy
Publications * Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Güneş M, Gökoğlan Y, Gianni C, Horton RP, Themistoclakis S, Gallinghouse GJ, Bailey S, Zagrodzky JD, Hongo RH, Beheiry S, Santangeli P, Casella M, Dello Russo A, Al-Ahmad A, Hranitzky P, Lakkireddy D, Tondo C, Natale A. Left Atrial Appendage Isolation in Patients With Longstanding Persistent AF Undergoing Catheter Ablation: BELIEF Trial. J Am Coll Cardiol. 2016 Nov 1;68(18):1929-1940. doi: 10.1016/j.jacc.2016.07.770.

*   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: May 27, 2011)
156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18-75 years
  2. History of PeAF or LSP AF refractory to antiarrhythmic drugs
  3. Willing and ability to understand and sign an informed consent

Exclusion Criteria:

  1. Reversible causes of AF (hyperthyroidism)
  2. Left atrial thrombus
  3. Moderate to severe valvular heart disease
  4. Contraindication for anticoagulation
  5. Life expectancy < 12 months
  6. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (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 NCT01362738
Other Study ID Numbers  ICMJE TCAI_BELIEF
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 Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
PRS Account Texas Cardiac Arrhythmia Research Foundation
Verification Date October 2016

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