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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT00665587
Other study ID # 121402
Secondary ID
Status Unknown status
Phase N/A
First received April 23, 2008
Last updated April 23, 2008
Start date June 2007
Est. completion date June 2012

Study information

Verified date April 2008
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Unknown status
Enrollment 220
Est. completion date June 2012
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Procedure:
Cox-MAZE III
Maze procedure according to standards of the department

Locations

Country Name City State
Czech Republic Cardiosurgery Department of University Hospital in Pilsen Pilsen
Czech Republic Cardiocentre of Kralovske Vinohrady University Hospital Prague
Czech Republic Cardiology department of Masarykova Hospital Usti nad Labem Usti nad Labem

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary presence of sinus rhythm 1 year after surgery
Primary death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis 30 postoperative days
Secondary 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
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