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Clinical Trials/NCT00665587
NCT00665587
Unknown
Not Applicable

Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Charles University, Czech Republic3 sites in 1 country220 target enrollmentJune 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Charles University, Czech Republic
Enrollment
220
Locations
3
Primary Endpoint
presence of sinus rhythm
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
June 2012
Last Updated
18 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Charles University, Czech Republic

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

Outcomes

Primary Outcomes

presence of sinus rhythm

Time Frame: 1 year after surgery

death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis

Time Frame: 30 postoperative days

Secondary Outcomes

  • 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)

Study Sites (3)

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