NCT00665587

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

April 23, 2008

Last Update Submit

April 23, 2008

Conditions

Atrial FibrillationRestore of Sinus RhythmPost-Operative Complications

Keywords

Atrial fibrillationMaze procedureMid-term resultsLong-term resultsSurgical ablation

Outcome Measures

Primary Outcomes (2)

  • presence of sinus rhythm

    1 year after surgery

  • death, myocardial infarction, vascular cerebral attack, renal failure with a need of haemodyalisis

    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...

    1,3,5 months 1,5 years after surgery

Study Arms (2)

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

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).

Interventions

Cox-MAZE IIIPROCEDURE

Maze procedure according to standards of the department

A = MAZE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

  • rejection of signing the informed consent with randomization
  • emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardiosurgery Department of University Hospital in Pilsen

Pilsen, 305 99, Czechia

Location

Cardiocentre of Kralovske Vinohrady University Hospital

Prague, 10034, Czechia

Location

Cardiology department of Masarykova Hospital Usti nad Labem

Ústí nad Labem, 40113, Czechia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Maze Procedure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, OperativeCardiac Surgical ProceduresCardiovascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Zbynek Straka, Prof.,MUDr.,CSc.

    Charles University, Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2008

First Posted

April 24, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2012

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

CZ(3)