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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A = MAZE | 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 |
| |
| B = non-MAZE | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cox-MAZE III | Procedure | Maze procedure according to standards of the department |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who suffer from atrial fibrillation (documented AF in 6 month before the surgery) but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery)
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| Name | Affiliation | Role |
|---|---|---|
| Zbynek Straka, Prof.,MUDr.,CSc. | Charles University, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiosurgery Department of University Hospital in Pilsen | Pilsen | 305 99 | Czechia | |||
| Cardiocentre of Kralovske Vinohrady University Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 27, 2017 | |
| Reset | Apr 7, 2017 | |
| Release | Jul 18, 2018 | |
| Reset | Jan 11, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 27, 2017 | Apr 7, 2017 | |||
| Jul 18, 2018 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000079042 | Maze Procedure |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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| Prague |
| 10034 |
| Czechia |
| Cardiology department of Masarykova Hospital Usti nad Labem | Ústí nad Labem | 40113 | Czechia |
| Jan 11, 2019 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019616 | Thoracic Surgical Procedures |