An observational study in Atrial Fibrillation, Restore of Sinus Rhythm and Post-Operative Complications, sponsored by Charles University, Czech Republic. Status unknown at 3 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-24.
Sponsored by Charles University, Czech Republic · Observational
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 220 is below the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Charles University, Czech Republic is the lead sponsor of 227 studies on the registry; 76 are open to participants now.
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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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Exclusion Criteria:
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
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).
Maze procedure according to standards of the department
presence of sinus rhythm
Time frame: 1 year after surgery
death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis
Time frame: 30 postoperative days
mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation...
Time frame: 1,3,5 months 1,5 years after surgery
This study is status unknown, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Charles University, Czech Republic →