Clinical trial NCT00665587: AMAZING PRAGUE (PRAGUE-12)
Official title: Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Restore of Sinus Rhythm
Post-Operative Complications
Keywords: Atrial fibrillation
Maze procedure
Mid-term results
Long-term results
Surgical ablation
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2008-04-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: presence of sinus rhythm
timeFrame: 1 year after surgery
measure: death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis
timeFrame: 30 postoperative days
Secondary outcomes:
measure: mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation...
timeFrame: 1,3,5 months 1,5 years after surgery
Other outcomes:
Locations:
city: Pilsen
country: Czech Republic
facility: Cardiosurgery Department of University Hospital in Pilsen
city: Prague
country: Czech Republic
facility: Cardiocentre of Kralovske Vinohrady University Hospital
city: Usti nad Labem
country: Czech Republic
facility: Cardiology department of Masarykova Hospital Usti nad Labem
Study officials:
affiliation: Charles University, Prague
name: Zbynek Straka, Prof.,MUDr.,CSc.
role: PRINCIPAL_INVESTIGATOR
References: