Predictive Factors to Effectively Terminate Paroxysmal Atrial Fibrillation by Blocking Atrial Selective Ionic Currents
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
- The main objective of this project is to study the efficacy and the mechanistic value of
blocking both atrial specific and atria-preferential dynamics of ionic currents to
terminate paroxysmal atrial fibrillation (AF).
- The hypothesis is that a drug blocking atrial specific and atria-preferential dynamics
of ionic currents (IK,ACh - acetylcholine sensitive K+ current - and INa - inward sodium
current - , respectively) will be more effective to terminate paroxysmal AF episodes
with fast atrial activation rates, than a classical INa blocker, which will be more
effective to terminate AF episodes with slower activation rates.
- The investigators will include patients without structural heart disease and
short-lasting AF episodes (<48 h.). Double blind and single center study, in which
patients will be randomly assigned to a cardioversion group using intravenous flecainide
or to an atria-preferential and atrial-specific blockade group using intravenous
vernakalant. Patients will be routinely monitored in the electrophysiology room to
acquire both 12-lead digitized ECG signals and non-invasive body surface potential
mapping. Atrial signals will be extracted from both the multisite body surface and ECG
recordings to obtain temporal and spectral parameters, and measure organization and
atrial rate in both groups. The results obtained in the clinical setting will be studied
in mathematical models to understand their capability to terminate paroxysmal AF. The
project expects to provide consistent, reliable and reproducible parameters that will
assist clinicians to know what type of paroxysmal AF episodes will be more suitable to
effectively terminate, upon administration of drugs with an atrial specific and
atria-preferential profile.
Phase:
Phase 4
Details
Lead Sponsor:
David Filgueiras-Rama
Collaborator:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III