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DISCOntinuation VERsus continuation of antiarrhythmic drugs prior to Pulmonary Vein Isolation for atrial fibrillation and influence on dormant conduction with adenosine; a randomised controlled trial.


- candidate number22821
- NTR NumberNTR5437
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2015
- Secondary IDsNL54134.044.15;P15-020 CCMO / toetsing online;METC Twente
- Public TitleDISCOntinuation VERsus continuation of antiarrhythmic drugs prior to Pulmonary Vein Isolation for atrial fibrillation and influence on dormant conduction with adenosine; a randomised controlled trial.
- Scientific TitleDISCOntinuation VERsus continuation of antiarrhythmic drugs prior to Pulmonary Vein Isolation for atrial fibrillation and influence on dormant conduction with adenosine; a randomised controlled trial.
- ACRONYMDISCOVER PVI
- hypothesisAs current guidelines donít recommend continuation or cessation of AAD prior to pulmonary vein isolation we compare continuing antiarrythmic drugs prior to PVI to cessation of AADís in relation to the occurence of dormant conduction with adenosine after succesful PVI.
- Healt Condition(s) or Problem(s) studiedAtrial Fibrillation, Antiarrhythmic drugs , Pulmonary Vein Isolation
- Inclusion criteriaAdults with atrial fibrillation EHRA class II or higher during therapy with class I or III (excluding amiodaron) antiarrhythmic drugs eligible for PVI.
- Exclusion criteria-Usage of amiodaron (due to very long half life time(20-100 days) these patients will be excluded)
-Prior PVI or MAZE
- Asthmatic condition or contra indication for adenosine
-Participation in another study that is interfering with study practice
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate1-okt-2018
- Target number of participants188
- InterventionsContinuation or discontinuation of antiarrhythmic drugs 5 half lives prior to PVI
- Primary outcomeIncidence of dormant conduction with adenosine challenge after initial successful PVI.
- Secondary outcome1. Incidence of AF during cessation of AAD drugs.
2. Recurrence of AF within 12 months of the procedure on ECG or >30 seconds on Holter/Vitaphone (With applied blanking period of 3 months)
- TimepointsAcute and 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES T. Hesselink
- CONTACT for SCIENTIFIC QUERIES T. Hesselink
- Sponsor/Initiator MST Enschede
- Funding
(Source(s) of Monetary or Material Support)
Cardio Research Enschede BV
- Publications
- Brief summaryAntiarrhythmic medications are frequently stopped more than five half-lives before pulmonary vein isolation(PVI) with the idea that they can supress spontaneous firing and fractionation of the electrocardiograms that can be used to guide ablation. Therefore they might mask dormant conduction in pulmonary veins. However many institutions choose to continue antiarrhythmic drugs(AAD) periprocedural. As current guidelines donít recommend continuation or cessation of AAD prior to pulmonary vein isolation we compare continuing antiarrythmic drugs prior to PVI to cessation of AADís in relation to the occurence of dormant conduction.
- Main changes (audit trail)
- RECORD1-sep-2015 - 18-nov-2015


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