Atrial FibrillationAmPNCT00665587
AMAZING PRAGUE (PRAGUE-12)
An observational study of Atrial Fibrillation and Restore of Sinus Rhythm, run by Charles University, Czech Republic at 3 sites in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Restore of Sinus Rhythm, Post-Operative Complications
- What is being tested?
- Cox-MAZE III
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 3 sitesCzechia
- Study dates
- Jun 2007to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- rejection of signing the informed consent with randomization
- emergent surgery
Trial locations and contacts
3 sites in 1 country.
Czechia3 sites
Cardiosurgery Department of University Hospital in Pilsen
Pilsen, 305 99
Cardiocentre of Kralovske Vinohrady University Hospital
Prague, 10034
Cardiology department of Masarykova Hospital Usti nad Labem
Ústí nad Labem, 40113
About this study
Official title: Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
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.
- Being tested
- Cox-MAZE III
- Keywords
- Atrial fibrillation, Maze procedure, Mid-term results, Long-term results, Surgical ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cox-MAZE IIIProcedure or surgery
Maze procedure according to standards of the department
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of sinus rhythm
Measured: 1 year after surgery
death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis
Measured: 30 postoperative days
Secondary outcomes (1)
mortality, presence of sinus rhythm, serious complications- bleeding, vascular cerebral attack, heart failure, anticoagulation, anti-arrhytmics, pacemaker or ICD implantation, catether ablation...
Measured: 1,3,5 months 1,5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2009 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Zbynek Straka, Prof.,MUDr.,CSc., Principal investigator, Charles University, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665587
- Sponsor's protocol ID
- 121402
- Acronym
- AmP
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Atrial Fibrillation - Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00665587
- Acronym / sponsor ID
- AmP / 121402
- Keywords
- Atrial fibrillation, Maze procedure, Mid-term results, Long-term results, Surgical ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A = MAZE | – | Procedure: Cox-MAZE IIIPatients 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 |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- rejection of signing the informed consent with randomization
- emergent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cox-MAZE IIIMaze procedure according to standards of the department | Procedure or surgery | A = MAZE |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zbynek Straka, Prof.,MUDr.,CSc. principal investigator
Charles University, Prague
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Restore of Sinus Rhythm, run by Charles University, Czech Republic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of sinus rhythm (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2008; AzTrials last refreshed its copy on 29 Oct 2026.