AMAZING PRAGUE (PRAGUE-12)

Study Overview
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Brief Summary
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Aim of the project is to assess the long-time clinical impact of surgical ablation (MAZE procedure) on patients who suffer from atrial fibrillation but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery). In recent years, those patients are more and more frequently indicated to some type of MAZE procedure, without the real benefit of this procedure for patients has been assessed with an enough large, randomized study. Even though it is well known, that MAZE procedures declines the early postoperative incidence of atrial fibrillation, convincing data about its mid-term and long-term impact on patients and about the appearance of recidives of atrial fibrillation in long-time horizon are still missing. Our hypothesis assumes, that MAZE procedure will significantly decrease the appearance of atrial fibrillation one year after the operation, without increasing mortality or incidence of serious postoperative complications in thirty postoperative days.

Official Title
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Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Conditions
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Atrial Fibrillation, Restore of Sinus Rhythm, Post-Operative Complications

Intervention / Treatment
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* Procedure: Cox-MAZE III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication to a cardiac surgery (coronary bypass, valve repair, others or combination of those) atrial fibrillation (paroxysmal, persistent or permanent) present or documented in last 6 month before the operation signed informed consent Exclusion Criteria: rejection of signing the informed consent with randomization emergent surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A = MAZE<br>Patients indicated to a cardiac surgery (bypass, valve repair or combinated surgery)with documented atrial fibrillation in 6 preoperative months undergo the operation together with MAZE procedure | Procedure: Cox-MAZE III<br>* Maze procedure according to standards of the department<br>|
| B = non-MAZE<br>Patients indicated to a cardiac surgery (bypass, valve repair or combinated surgery)with documented atrial fibrillation in 6 preoperative months undergo the operation (without MAZE procedure). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of sinus rhythm |  | 1 year after surgery | 
| death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis |  | 30 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation... |  | 1,3,5 months 1,5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Maze procedure, Mid-term results, Long-term results, Surgical ablation