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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- Hospitalization due to atrial fibrillation after surgery [ Time Frame: Within three years after surgery ]All cases of hospitalization due to atrial fibrillation after surgery
- Cardiovascular events [ Time Frame: Within three years after surgery ]All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
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
|Contact: Julia Karevafirstname.lastname@example.org|
|Meshalkin State Research Institute of Circulation Pathology||Recruiting|
|Novosibirsk, Russian Federation, 630055|
|Contact: Julia Kareva, PhD +79069952839 email@example.com|