Atrial Fibrillation Clinical Trial
— AmPOfficial title:
Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
Verified date | April 2008 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic |
Czech Republic,
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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