AMAZING PRAGUE (PRAGUE-12)

Atrial Fibrillation Clinical Trial

— AmP  

Official title:

Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00665587
• Other study ID #: 121402
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-Operative Complications
• Postoperative Complications
• Restore of Sinus Rhythm

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