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
1 other identifier
interventional
156
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2010
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedApril 26, 2017
October 1, 2016
3.6 years
May 26, 2011
April 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from AF/ATs
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting \>30 seconds at follow-up
12 months
Secondary Outcomes (1)
Severe adverse events due to cardiac cause
12 months
Study Arms (2)
Ablation of PV and extra-PV triggers
ACTIVE COMPARATORConventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers
LAA isolation along with the conventional ablation strategy
ACTIVE COMPARATORLAA isolation along with the conventional ablation strategy
Interventions
PVAI and isolation of extra PV triggers
PVAI + isolation of extra PV triggers + LAA isolation
Eligibility Criteria
You may qualify if:
- years
- History of PeAF or LSP AF refractory to antiarrhythmic drugs
- Willing and ability to understand and sign an informed consent
You may not qualify if:
- Reversible causes of AF (hyperthyroidism)
- Left atrial thrombus
- Moderate to severe valvular heart disease
- Contraindication for anticoagulation
- Life expectancy \< 12 months
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St. David's Medical Center
Austin, Texas, 78705, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705, United States
Related Publications (1)
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.
PMID: 27788847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
November 1, 2010
Primary Completion
June 1, 2014
Study Completion
November 1, 2016
Last Updated
April 26, 2017
Record last verified: 2016-10