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AMAZING PRAGUE (PRAGUE-12) (AmP)

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ClinicalTrials.gov Identifier: NCT00665587
Recruitment Status : Unknown
Verified April 2008 by Charles University, Czech Republic.
Recruitment status was:  Enrolling by invitation
First Posted : April 24, 2008
Last Update Posted : April 24, 2008
Sponsor:
Information provided by:
Charles University, Czech Republic

Tracking Information
First Submitted Date April 23, 2008
First Posted Date April 24, 2008
Last Update Posted Date April 24, 2008
Study Start Date June 2007
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2008)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 23, 2008)
mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation... [ Time Frame: 1,3,5 months 1,5 years after surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title AMAZING PRAGUE (PRAGUE-12)
Official Title Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who suffer from atrial fibrillation (documented AF in 6 month before the surgery) but are indicated to a cardiac surgery for other predominant cardiac diagnosis (heart valve surgery, coronary revascularization or combined surgery)
Condition
  • Atrial Fibrillation
  • Restore of Sinus Rhythm
  • Post-Operative Complications
Intervention Procedure: Cox-MAZE III
Maze procedure according to standards of the department
Study Groups/Cohorts
  • 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
    Intervention: Procedure: Cox-MAZE III
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 23, 2008)
220
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2012
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic
Removed Location Countries  
 
Administrative Information
NCT Number NCT00665587
Other Study ID Numbers 121402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Prof. MUDr. Zbynek Straka, CSc., Kralovske Vinohrady University Hospital
Study Sponsor Charles University, Czech Republic
Collaborators Not Provided
Investigators
Principal Investigator: Zbynek Straka, Prof.,MUDr.,CSc. Charles University, Prague
PRS Account Charles University, Czech Republic
Verification Date April 2008