No registrations found.
ID
Source
Brief title
Health condition
Epicardial, Mapping, Atrial Fibrillation, Cardiac Surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of the study is reached when atrial fibrillation develops. There is a follow-up period of 5 years after
cardiac surgery. Each year, the participant will be called by the investigator in order to check whether atrial fibrillation has
occurred.
Secondary outcome
N/A
Background summary
Background of the study:
Post-operative AF after isolated coronary bypass graft surgery affects not only early but also late mortality. The
exact mechanism of post-operative AF is still unknown. Subsequently, at present there are no diagnostic tools available to identify patients at risk pre-operatively.
Objective of the study:
To investigate whether high resolution multi-site epicardial mapping of the atria in patients with coronary artery disease undergoing cardiac surgery can identify patients at risk for developing early post-operative atrial fibrillation. The acquired knowledge will be used in clinical practice to ensure an appropriate selection of patients for AF therapy and to improve existing AF treatment modalities.
Study design:
This study is designed as an observational study. Patients will be recruited at the department of thoracic surgery. The
investigator is responsible for patient selection and appropriate inclusion. Patients scheduled for routine open chest surgery will be asked to participate in this study.
Study population:
Patients scheduled for standard coronary artery bypass grafting will be studied. Patients will be recruited at the
department of cardiology and cardiothoracic surgery. Routine surgical procedures are being performed daily. At least 2-4 patients will be included every week. Each patient, prior to enrolling in the study, will be provided with a written explanation of the study procedure together with an assessment of risks in participating in the study. Written informed consent will be obtained from all patients; no patient will be enrolled if the consent form is not signed. The informed consent form will also be signed by the investigator.
Primary study parameters/outcome of the study:
The main endpoint of the study is reached when atrial fibrillation develops. There is a follow-up period of 5 years after cardiac surgery. Each year, the participant will be called by the investigator in order to check whether atrial fibrillation has occurred.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Max extension of 10 minutes of CABG surgery
Study objective
Post-operative AF after isolated coronary bypass graft surgery affects not only early but also late mortality. The exact mechanism of post-operative AF is still unknown. Subsequently, at present there are no diagnostic tools available to identify patients at risk pre-operatively.
Objective:
To investigate whether high resolution multi-site epicardial mapping of the atria in patients with coronary artery disease undergoing cardiac surgery can identify patients at risk for developing early post-operative atrial fibrillation. The acquired knowledge will be used in clinical practice to ensure an appropriate selection of patients for AF therapy and to improve existing AF treatment modalities.
Study design
Pre-op, procedure, FU postop 1, 2, 3, 4 and 5 years.
Intervention
Epicardial mapping.
N.M.S. Groot, de
Erasmus MC, afdeling Cardiologie, Kamer BA-579
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7034479
n.m.s.degroot@erasmusmc.nl
N.M.S. Groot, de
Erasmus MC, afdeling Cardiologie, Kamer BA-579
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7034479
n.m.s.degroot@erasmusmc.nl
Inclusion criteria
All patients > 18 years scheduled for standard coronary bypass grafting.
Exclusion criteria
1. Paced atrial rhythms;
2. Usage of anti-arrhythmic drugs;
3. Hemodynamic instability;
4. Presence of assist devices;
5. Usage of inotropic agents;
6. Emergency cardiac surgery;
7. Redo-cardiac surgery;
8. History of atrial fibrillation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL2431 |
NTR-old | NTR2540 |
Other | MEC Erasmus MC / THCHOZ : 2010-054 / 2009-013 ; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |