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Elektrode studie.


- candidate number8511
- NTR NumberNTR2540
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2010
- Secondary IDs2010-054 / 2009-013 ; MEC Erasmus MC / THCHOZ
- Public TitleElektrode studie.
- Scientific TitleEpicardial Mapping Studies in Patients undergoing Cardiac Surgery.
- ACRONYMElektrode studie
- hypothesisPost-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.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Cardiac surgery, Epicardial, Mapping
- Inclusion criteriaAll patients > 18 years scheduled for standard coronary bypass grafting.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2010
- planned closingdate1-sep-2011
- Target number of participants100
- InterventionsEpicardial mapping.
- Primary outcomeThe 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 outcomeN/A
- TimepointsPre-op, procedure, FU postop 1, 2, 3, 4 and 5 years.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMrs. Dr. N.M.S. Groot, de
- CONTACT for SCIENTIFIC QUERIESMrs. Dr. N.M.S. Groot, de
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryBackground 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
- Main changes (audit trail)
- RECORD29-sep-2010 - 12-okt-2010


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