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AMAZING PRAGUE (PRAGUE-12) (AmP)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00665587
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Restore of Sinus Rhythm
Post-Operative Complications
Procedure: Cox-MAZE III

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • presence of sinus rhythm [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
  • death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Procedure: Cox-MAZE III
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665587

Locations
Czech Republic
Cardiosurgery Department of University Hospital in Pilsen
Pilsen, Czech Republic, 305 99
Cardiocentre of Kralovske Vinohrady University Hospital
Prague, Czech Republic, 10034
Cardiology department of Masarykova Hospital Usti nad Labem
Usti nad Labem, Czech Republic, 40113
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Zbynek Straka, Prof.,MUDr.,CSc. Charles University, Prague
  More Information

No publications provided

Responsible Party: Prof. MUDr. Zbynek Straka, CSc., Kralovske Vinohrady University Hospital
ClinicalTrials.gov Identifier: NCT00665587     History of Changes
Other Study ID Numbers: 121402
Study First Received: April 23, 2008
Last Updated: April 23, 2008
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Charles University, Czech Republic:
Atrial fibrillation
Maze procedure
Mid-term results
Long-term results
Surgical ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Postoperative Complications
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014