Comparing incidence of dormant conduction after adenosine challenge and initial succesfull PVI in a strategy of cessation of antiarrhythmic drugs compared with continuation prior to PVI.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of dormant conduction with adenosine challenge after initial
successful PVI.
Secondary outcome
1. Incidence of AF prior to PVI.
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)
Background summary
Antiarrhythmic medications are frequently stopped more than 5 days (more than
five half-lives) before the ablation procedure with the idea that they can
suppress 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. Current guidelines do not make recommendations
regarding continuation or cessation of AAD prior to pulmonary vein
isolation(PVI). Several studies have reported reported that an adenosine/ATP
challenge can identify dormant pulmonary vein conduction and that ablation
based on this approach reduces AF recurrence after PVI. Therefore we compare a
strategy continuing antiarrythmic drugs prior to ablation with a strategy of
cessation of antiarrythmic drugs employing revelation of dormant conduction
with adenosine as primary outcome point.
Study objective
Comparing incidence of dormant conduction after adenosine challenge and initial
succesfull PVI in a strategy of cessation of antiarrhythmic drugs compared with
continuation prior to PVI.
Study design
Single center randomised controlled trial.
Intervention
Group 1: Continuation of AAD
Group 2: Discontinuation 5 half lives prior to PVI of AAD
Study burden and risks
Patients discontinuing AAD therapy might experience AF. Current guidelines
allow both strategies to be employed prior to PVI.
Ariënsplein 1
Enschede 7511 JX
NL
Ariënsplein 1
Enschede 7511 JX
NL
Listed location countries
Age
Inclusion criteria
Adults
Atrial fibrillation greater or equal to EHRA class II accepted for pulmonary vein isolation according to current guidelines
Using class I or class III antiarrythmic drugs with exception of amiodaron (e.g. flecainide, sotalol)
Willing and able to sign informed consent
Exclusion criteria
Usage of amiodaron (due to very long half life time(20-100 days) these patients will be excluded)
Prior PVI or MAZE
Severe asthmatic condition or contra indication for adenosine
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54134.044.15 |
| Other | volgt via trialregister.nl |
| OMON | NL-OMON29546 |