Paroxysmal Atrial Fibrillation, Coronary Artery DiseasePhase 3NCT02246803
The Assessment of Progression of Paroxysmal AF After CABG
A Phase 3 study testing CABG+Pulmonary vein isolation procedure and Isolated CABG in people with Paroxysmal Atrial Fibrillation, Coronary Artery Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- CABG+Pulmonary vein isolation procedure and Isolated CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteRussia
- Study dates
- Jan 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 80 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) symptomatic paroxysmal atrial fibrillation episodes 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
Julia Kareva, PhD, +79069952839, julia11108@mail.ru
About this study
Official title: The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
Read the detailed description
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
- Being tested
- CABG+Pulmonary vein isolation procedure, Isolated CABG
- Keywords
- paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG+Pulmonary vein isolation procedureProcedure or surgery
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
Isolated CABGProcedure or surgery
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.
| Study group | Role | What they receive |
|---|---|---|
| CABG+pulmonary vein isolation | Active comparator | CABG+pulmonary vein isolation procedure Receives: Procedure: CABG+Pulmonary vein isolation procedure |
| Isolated CABG | Active comparator | Isolated CABG procedure Receives: Procedure: Isolated CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of atrial fibrillation
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.
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 (2)
Hospitalization due to atrial fibrillation after surgery
All cases of hospitalization due to atrial fibrillation after surgery
Measured: Within three years after surgery
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 startJan 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 Paroxysmal Atrial Fibrillation, 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
- 72 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
- NCT02246803
- Sponsor's protocol ID
- AF-Progress
- Status last verified
- Sep 2015
- First submitted
- 19 Sep 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
- ClinicalTrials.gov ID
- NCT02246803
- Acronym / sponsor ID
- AF-Progress
- Keywords
- paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 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.
The aim of this study is a comparative evaluation of progression of paroxysmal atrial fibrillation in patients with coronary artery disease after isolated CABG and CABG combined with pulmonary vein isolation.
Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery disease after CABG in combination with isolation of the pulmonary veins have a better outcomes for the progression of AF compared with patients undergoing isolated CABG.
Detailed description
This is a single blinded prospective randomized study involving 72 patients with paroxysmal AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG + pulmonary veins isolation group over isolated CABG group. Patients are divided into two groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins isolation (36 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 pulmonary vein isolation. 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 |
|---|---|---|
| CABG+pulmonary vein isolation | Active comparator | Procedure: CABG+Pulmonary vein isolation procedureCABG+pulmonary vein isolation procedure |
| Isolated CABG | Active comparator | Procedure: Isolated CABGIsolated CABG procedure |
Who may qualify
- Ages
- 18 to 80 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) symptomatic paroxysmal atrial fibrillation episodes 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 |
|---|---|---|
| CABG+Pulmonary vein isolation procedureCoronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG | Procedure or surgery | CABG+pulmonary vein isolation |
| Isolated CABGCoronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. | Procedure or surgery | Isolated CABG |
Primary outcome
Progression of atrial fibrillation
Time frame: up to 36 months
Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
2 secondary outcomes
Hospitalization due to atrial fibrillation after surgery
Time frame: Within three years after surgery
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 23 Sep 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 CABG+Pulmonary vein isolation procedure and Isolated CABG in people with Paroxysmal Atrial Fibrillation, 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 23 Sep 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 Julia Kareva (+79069952839, julia11108@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of 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 23 Sep 2015.