AMAZING PRAGUE (PRAGUE-12) (AmP)

Charles University, Czech Republic

Status: Unknown

Conditions: Restore of Sinus Rhythm; Post-Operative Complications; Atrial Fibrillation

Treatments: Procedure: Cox-MAZE III

Study type: Observational

Funder types: Other

Identifiers

NCT00665587

121402

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

220 participants in 2 patient groups

A = MAZE

Description:

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

Treatment:

Procedure: Cox-MAZE III

B = non-MAZE

Description:

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).