Atrial Fibrillation, Post-Operative Complications, Restore of Sinus Rhythm
Conditions
Keywords
Atrial fibrillation, Maze procedure, Mid-term results, Long-term results, Surgical ablation
Brief summary
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.
Interventions
PROCEDURECox-MAZE III
Maze procedure according to standards of the department
Sponsors
Charles University, Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Czechia
Outcome results
None listed