Persistent Atrial FibrillationPhase 3BELIEFNCT01362738
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
A Phase 3 study testing RFCA of PV and extra-PV triggers and LAA isolation along with the conventional ablation strategy in people with Persistent Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- RFCA of PV and extra-PV triggers and LAA isolation along with the conventional ablation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years
- History of PeAF or LSP AF refractory to antiarrhythmic drugs
- Willing and ability to understand and sign an informed consent
Who cannot join
- Reversible causes of AF (hyperthyroidism)
- Left atrial thrombus
- Moderate to severe valvular heart disease
- Contraindication for anticoagulation
- Life expectancy < 12 months
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. David's Medical Center
Austin, Texas, 78705
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
About this study
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.
Read the 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- RFCA of PV and extra-PV triggers, LAA isolation along with the conventional ablation strategy
- Keywords
- Long-standing persistent atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFCA of PV and extra-PV triggersProcedure or surgery
PVAI and isolation of extra PV triggers
LAA isolation along with the conventional ablation strategyProcedure or surgery
PVAI + isolation of extra PV triggers + LAA isolation
| Study group | Role | What they receive |
|---|---|---|
| Ablation of PV and extra-PV triggers | Active comparator | Conventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers Receives: Procedure: RFCA of PV and extra-PV triggers |
| LAA isolation along with the conventional ablation strategy | Active comparator | LAA isolation along with the conventional ablation strategy Receives: Procedure: LAA isolation along with the conventional ablation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF/ATs
Freedom from AF/ATs, defined as no episodes of AF/AT without AADs lasting >30 seconds at follow-up
Measured: 12 months
Secondary outcomes (1)
Severe adverse events due to cardiac cause
Severe adverse events (hospital admissions or death due to a cardiac cause)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Andrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362738
- Sponsor's protocol ID
- TCAI_BELIEF
- Acronym
- BELIEF
- Status last verified
- Oct 2016
- First submitted
- 26 May 2011
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27788847
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01362738
- Acronym / sponsor ID
- BELIEF / TCAI_BELIEF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Long-standing persistent atrial fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation of PV and extra-PV triggers | Active comparator | Procedure: RFCA of PV and extra-PV triggersConventional approach which includes pulmonary vein isolation (PVI) and ablation of extra-pulmonary triggers |
| LAA isolation along with the conventional ablation strategy | Active comparator | Procedure: LAA isolation along with the conventional ablation strategyLAA isolation along with the conventional ablation strategy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years
- History of PeAF or LSP AF refractory to antiarrhythmic drugs
- Willing and ability to understand and sign an informed consent
Key exclusion criteria (6 listed)
- Reversible causes of AF (hyperthyroidism)
- Left atrial thrombus
- Moderate to severe valvular heart disease
- Contraindication for anticoagulation
- Life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RFCA of PV and extra-PV triggersPVAI and isolation of extra PV triggers | Procedure or surgery | Ablation of PV and extra-PV triggers |
| LAA isolation along with the conventional ablation strategyPVAI + isolation of extra PV triggers + LAA isolation | Procedure or surgery | LAA isolation along with the conventional ablation strategy |
Primary outcome
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
1 secondary outcome
Severe adverse events due to cardiac cause
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 27788847Di 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RFCA of PV and extra-PV triggers and LAA isolation along with the conventional ablation strategy in people with Persistent Atrial Fibrillation, run by Texas Cardiac Arrhythmia Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF/ATs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.