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AMAZING PRAGUE (PRAGUE-12)

NCT ID: NCT00665587

Last Updated: 2008-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation Restore of Sinus Rhythm Post-Operative Complications

Keywords

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Atrial fibrillation Maze procedure Mid-term results Long-term results Surgical ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Cox-MAZE III

Intervention Type PROCEDURE

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).

No interventions assigned to this group

Interventions

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Cox-MAZE III

Maze procedure according to standards of the department

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Kralovske Vinohrady University Hospital

Principal Investigators

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Zbynek Straka, Prof.,MUDr.,CSc.

Role: PRINCIPAL_INVESTIGATOR

Charles University, Prague

Locations

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Cardiosurgery Department of University Hospital in Pilsen

Pilsen, , Czechia

Site Status

Cardiocentre of Kralovske Vinohrady University Hospital

Prague, , Czechia

Site Status

Cardiology department of Masarykova Hospital Usti nad Labem

Ústí nad Labem, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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121402

Identifier Type: -

Identifier Source: org_study_id