AMAZING PRAGUE (PRAGUE-12)

Charles University, Czech Republic220 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Atrial Fibrillation Restore of Sinus Rhythm Post-Operative Complications

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Cardiosurgery Department of University Hospital in Pilsen

Pilsen, Czechia

Cardiocentre of Kralovske Vinohrady University Hospital

Prague, Czechia

Cardiology department of Masarykova Hospital Usti nad Labem

Ústí nad Labem, Czechia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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