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Studie naar de relatie tussen elektrische signalen, bloedwaarden en weefsel eigenschappen en het ontwikkelen van boezemfibrilleren.


- candidate number18108
- NTR NumberNTR4658
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-jun-2014
- Secondary IDsNL 49785.078.14 MEC-2014-393
- Public TitleStudie naar de relatie tussen elektrische signalen, bloedwaarden en weefsel eigenschappen en het ontwikkelen van boezemfibrilleren.
- Scientific TitleHsf1 Activators Lower cardiomyocyte damage: Towards a novel therapeutic approach to REVERSE atrial fibrillation
- ACRONYMHALT & REVERSE
- hypothesisPatient with a low baseline HSP level are more likely to have atrial electropathology and to develop postprocedural atrial fibrillation.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Cardiac surgery, Electrical cardioversion
- Inclusion criteriaAdult (>18 yr) patients undergoing elective cardiac surgery, pulmonary vein isolation or electric cardioversion
- Exclusion criteriaPaced Atrial Rhythms
Hemodynamic Instability
Presence of Assist Devices
Usage of Inotropic Agents
Emergency Cardiac Surgery
Redo Cardiac Surgery
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate31-dec-2019
- Target number of participants300
- InterventionsIn patients undergoing cardiac surgery:
- Epicardial mapping
- Biopsie atrial appendage

In patients undergoing pulmonary vein isolation:
- Endovascular mapping

In all patients: bloodsamples for HSP determination
- Primary outcomeMain endpoint of the study is development or recurrence of AF, or completion of five year follow up period. We will test the correlation between HSP levels and development or recurrence of AF, and the correlation between degree of electropathology and development/recurrence of AF.
- Secondary outcome The relationship between the atrial conduction pattern as visualised by epicardial mapping and structural tissue characteristics will be tested.
- TimepointsT = 0: procedure
Follow up:
T = 1: 6 mo
T = 2: 12 mo
T = 3: 24 mo
T = 4: 36 mo
T = 5: 48 mo
T = 6: 60 mo
- Trial web sitetranslationalelectrophysiology.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)
- RECORD12-jun-2014 - 29-jul-2014


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