Trials / Unknown
UnknownNCT00665587
AMAZING PRAGUE (PRAGUE-12)
Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (estimated)
- Sponsor
- Charles University, Czech Republic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cox-MAZE III | Maze procedure according to standards of the department |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2009-06-01
- Completion
- 2012-06-01
- First posted
- 2008-04-24
- Last updated
- 2008-04-24
Locations
3 sites across 1 country: Czechia
Source: ClinicalTrials.gov record NCT00665587. Inclusion in this directory is not an endorsement.