AMAZING PRAGUE (PRAGUE-12)

• Conditions: Atrial Fibrillation; Restore of Sinus Rhythm; Post-Operative Complications
• Interventions: Procedure: Cox-MAZE III

• Registration Number: NCT00665587
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Status Verified: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-23
• Last Update Submitted: 2008-04-23
• Study First Posted: 2008-04-24
• Last Update Posted: 2008-04-24
• Primary Completion: 2009-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A = MAZE	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 together with MAZE procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Cardiocentre of Kralovske Vinohrady University Hospital; 🇨🇿 Prague, Czech Republic

Cardiology department of Masarykova Hospital Usti nad Labem; 🇨🇿 Usti nad Labem, Czech Republic

Cardiosurgery Department of University Hospital in Pilsen; 🇨🇿 Pilsen, Czech Republic