Coronary Artery DiseasePhase 3LABARFANCT02246790
Surgical Ablation of Long-standing Persistent AF During CABG
A Phase 3 study testing Biatrial radiofrequency ablation and CABG and Left atrial radiofrequency ablation and CABG in people with Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation. Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Biatrial radiofrequency ablation and CABG and Left atrial radiofrequency ablation and CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2014to Dec 2017
- 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
- American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG
- At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months
- The patient's consent to participate in the study
Who cannot join
- Intolerance of antiarrhythmic drugs
- Heart valve disease requiring invasive treatment
- Left atria more than 6.5 cm
- Prior cardiac surgery
- Active pacemaker treatment
- Active anti-arrhythmic treatment (AAD) class I and III
- Contraindication to oral anticoagulant/heparin treatment
- Ejection fraction less than 30 % (EF < 30 %) assessed by transthoracic echocardiography
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, 630055
Sardor Rakhmonov, +79231278557, sardor5507@mail.ru
About this study
Official title: Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
Read the detailed description
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
- Conditions
- Coronary Artery Disease
- Being tested
- Biatrial radiofrequency ablation and CABG, Left atrial radiofrequency ablation and CABG
- Keywords
- ablation, CABG, Long-standing persistent Atrial Fibrillation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biatrial radiofrequency ablation and CABGProcedure or surgery
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
Left atrial radiofrequency ablation and CABGProcedure or surgery
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
| Study group | Role | What they receive |
|---|---|---|
| Biatrial radiofrequency ablation and CABG | Active comparator | Biatrial radiofrequency ablation during CABG Receives: Procedure: Biatrial radiofrequency ablation and CABG |
| Left atrial radiofrequency ablation and CABG | Active comparator | Left atrial radiofrequency ablation during CABG Receives: Procedure: Left atrial radiofrequency ablation and CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation
Freedom from AF. All cases of AF after surgical intervention.
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
Measured: up to 36 months
Secondary outcomes (1)
Cardiovascular events
All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
Measured: Within three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246790
- Sponsor's protocol ID
- LABARFA
- Acronym
- LABARFA
- Status last verified
- Nov 2015
- First submitted
- 19 Sep 2014
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring
- ClinicalTrials.gov ID
- NCT02246790
- Acronym / sponsor ID
- LABARFA / LABARFA
- Conditions
- Coronary Artery Disease
- Keywords
- ablation, CABG, Long-standing persistent Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Sep 2014 (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.
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.
Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
Detailed description
This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biatrial radiofrequency ablation and CABG | Active comparator | Procedure: Biatrial radiofrequency ablation and CABGBiatrial radiofrequency ablation during CABG |
| Left atrial radiofrequency ablation and CABG | Active comparator | Procedure: Left atrial radiofrequency ablation and CABGLeft atrial radiofrequency ablation during CABG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG
- At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months
- The patient's consent to participate in the study
Key exclusion criteria (8 listed)
- Intolerance of antiarrhythmic drugs
- Heart valve disease requiring invasive treatment
- Left atria more than 6.5 cm
- Prior cardiac surgery
- Active pacemaker treatment
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 |
|---|---|---|
| Biatrial radiofrequency ablation and CABGCoronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB. | Procedure or surgery | Biatrial radiofrequency ablation and CABG |
| Left atrial radiofrequency ablation and CABGCoronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB. | Procedure or surgery | Left atrial radiofrequency ablation and CABG |
Primary outcome
Freedom from atrial fibrillation
Time frame: up to 36 months
Freedom from AF. All cases of AF after surgical intervention. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
1 secondary outcome
Cardiovascular events
Time frame: Within three years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biatrial radiofrequency ablation and CABG and Left atrial radiofrequency ablation and CABG in people with Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 8 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: status not confirmed, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sardor Rakhmonov (+79231278557, sardor5507@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2015.