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)
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RFCA of PV and extra-PV triggers
LAA isolation along with the conventional ablation strategy
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Long-standing persistent atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 18-75 years
- History of PeAF or LSP AF refractory to antiarrhythmic drugs
- Willing and ability to understand and sign an informed consent
Exclusion Criteria:
- Reversible causes of AF (hyperthyroidism)
- Left atrial thrombus
- Moderate to severe valvular heart disease
- Contraindication for anticoagulation
- Life expectancy < 12 months
- Pregnancy
Sites / Locations
- St. David's Medical Center
- Texas Cardiac Arrhythmia Research Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ablation of PV and extra-PV triggers
LAA isolation along with the conventional ablation strategy
Arm Description
Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers
LAA isolation along with the conventional ablation strategy
Outcomes
Primary Outcome Measures
Freedom from AF/ATs
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting >30 seconds at follow-up
Secondary Outcome Measures
Severe adverse events due to cardiac cause
Severe adverse events (hospital admissions or death due to a cardiac cause)
Full Information
NCT ID
NCT01362738
First Posted
May 26, 2011
Last Updated
April 25, 2017
Sponsor
Texas Cardiac Arrhythmia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01362738
Brief Title
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
Acronym
BELIEF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Long-standing persistent atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation of PV and extra-PV triggers
Arm Type
Active Comparator
Arm Description
Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers
Arm Title
LAA isolation along with the conventional ablation strategy
Arm Type
Active Comparator
Arm Description
LAA isolation along with the conventional ablation strategy
Intervention Type
Procedure
Intervention Name(s)
RFCA of PV and extra-PV triggers
Intervention Description
PVAI and isolation of extra PV triggers
Intervention Type
Procedure
Intervention Name(s)
LAA isolation along with the conventional ablation strategy
Intervention Description
PVAI + isolation of extra PV triggers + LAA isolation
Primary Outcome Measure Information:
Title
Freedom from AF/ATs
Description
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting >30 seconds at follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Severe adverse events due to cardiac cause
Description
Severe adverse events (hospital admissions or death due to a cardiac cause)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years
History of PeAF or LSP AF refractory to antiarrhythmic drugs
Willing and ability to understand and sign an informed consent
Exclusion Criteria:
Reversible causes of AF (hyperthyroidism)
Left atrial thrombus
Moderate to severe valvular heart disease
Contraindication for anticoagulation
Life expectancy < 12 months
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27788847
Citation
Di Biase L, Burkhardt JD, Mohanty P, Mohanty S, Sanchez JE, Trivedi C, Gunes M, Gokoglan 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.
Results Reference
derived
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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
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