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The Assessment of Progression of Paroxysmal AF After CABG

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ClinicalTrials.gov Identifier: NCT02246803
Recruitment Status : Unknown
Verified September 2015 by Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : September 23, 2014
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation, Coronary Artery Disease Procedure: CABG+Pulmonary vein isolation procedure Procedure: Isolated CABG Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting Through Continuous Subcutaneous Monitoring
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CABG+pulmonary vein isolation
CABG+pulmonary vein isolation procedure
Procedure: CABG+Pulmonary vein isolation procedure
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG

Active Comparator: Isolated CABG
Isolated CABG procedure
Procedure: Isolated CABG
Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Hospitalization due to atrial fibrillation after surgery [ Time Frame: Within three years after surgery ]
    All cases of hospitalization due to atrial fibrillation after surgery

  2. Cardiovascular events [ Time Frame: Within three years after surgery ]
    All cases of stroke, cardiac infarction, thromboembolism, bleeding and death



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246803


Contacts
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Contact: Julia Kareva +79069952839 julia11108@mail.ru

Locations
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Russian Federation
Meshalkin State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Julia Kareva, PhD    +79069952839    julia11108@mail.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02246803     History of Changes
Other Study ID Numbers: AF-Progress
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Alexander Romanov, Meshalkin Research Institute of Pathology of Circulation:
paroxysmal atrial fibrillation, CABG, pulmonary vein isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases