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Dissociation of electrical signals between layers of the heart and development of atrial fibrillation


- candidate number22768
- NTR NumberNTR5370
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2015
- Secondary IDsNL50711.078.15  MEC 2015-373
- Public TitleDissociation of electrical signals between layers of the heart and development of atrial fibrillation
- Scientific TitleEpicardial and Endocardial mapping of Atrial Fibrillation
- ACRONYMEPIC END
- hypothesisPersistent atrial fibrillation is associated with (increased) dissociation between the sub-endocardial and sub-epicardial layers of the atria
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Cardiac surgery
- Inclusion criteria> 18 years
structural heart disease
scheduled for elective cardiothoracic surgery
- Exclusion criteriapaced atrial rhythms
hemodynamic instability
presence of assist devices
usage of inotropic agents
emergency cardiac surgery
redo-cardiac surgery
prior ablative therapy in the atria
Wolff-Parkinson-White syndrome
LVEF < 40%
prior radiation of the chest for malignancies
kidney or renal failure
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate
- Target number of participants150
- InterventionsEndo-epicardial mapping during (induced) atrial fibrillation, atrial fibrillation induced by high frequency pacing
- Primary outcomeelectrical dissociation between endo- and epicardium
- Secondary outcomedevelopment of persistent atrial fibrillation during 5 years of follow-up and relationship to electrical dissociation between endo- and epicardium
- TimepointsMapping procedure at T=0.
Follow-up for atrial fibrillation progression at:
T=1; 6 months
T=2; 12 months
T=3; 24 months
T=4; 36 months
T=5; 48 months
T=6; 60 months
- Trial web sitehttp://translationalelectrophysiology.erasmusmc.nl/
- statusplanned
- 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)
European Union
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD20-aug-2015 - 26-aug-2015


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