AmP: AMAZING PRAGUE (PRAGUE-12)

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Unknown status

CT.gov ID

NCT00665587

Collaborator

(none)

220

Enrollment

Locations

Duration (Months)

73.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Restore of Sinus Rhythm Post-Operative Complications	Procedure: Cox-MAZE III

Study Design

Study Type:

Observational

Anticipated Enrollment :

220 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Study Start Date :

Jun 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
A = MAZE 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 Maze procedure according to standards of the department
B = non-MAZE 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).

Arm

Intervention/Treatment

A = MAZE

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

Maze procedure according to standards of the department

B = non-MAZE

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).

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cardiosurgery Department of University Hospital in Pilsen	Pilsen	Czech Republic	305 99
2	Cardiocentre of Kralovske Vinohrady University Hospital	Prague	Czech Republic	10034
3	Cardiology department of Masarykova Hospital Usti nad Labem	Usti nad Labem	Czech Republic	40113