Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The broad, long-term objective of this project is to evaluate the therapeutic value of vein
of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation
(AF). AF is the most common sustained arrhythmia in adults, and it is a leading cause of
stroke, disability and increased mortality. Catheter ablation - pulmonary vein (PV) antral
isolation (PVAI)- can lead to cure, but is best suited for paroxysmal AF, in which ectopic
beats arising from the pulmonary veins were shown to initiate AF. PVAI success is lower in
persistent AF, in which the role of the cardiac autonomic system, particularly the intrinsic
cardiac ganglia, is being increasingly recognized. Expanding the ablation lesions to include
greater areas the left atrial (LA) anatomy marginally improves outcomes, but also leads to
increases in procedural complexity and duration, need of repeat procedures, and complications
such as atrial flutters, particularly perimitral flutter (PMF). The investigators have
developed a technique to perform rapid ablation of atrial tissues in AF using ethanol
infusion in the vein of Marshall (VOM), and have shown: 1) Effective, rapid and safe tissue
ablation of LA tissue neighboring the LA ridge and left inferior PV; 2) Regional LA vagal
denervation by reaching the intrinsic cardiac ganglia; and 3) Facilitation of cure of PMF by
ablating most of the mitral isthmus.
The investigators propose to evaluate outcomes differences yielded by VOM ethanol when added
to conventional PVAI. The specific aims are: #1.To assesses the impact of VOM ethanol
infusion in procedure success when added to de novo catheter ablation of persistent AF. The
investigators will randomize patients with persistent AF undergoing a first AF ablation to
standard PVAI vs. a combined VOM ethanol infusion plus PVAI (VOM-PV) #2. To assess the impact
of VOM ethanol infusion added to repeat catheter ablation of recurrent AF after a failed
ablation. Patients undergoing a repeat procedure for persistent AF after a failed PVAI will
be randomized to either PVAI or VOM-PV as their repeat procedure. End points will include
freedom from symptomatic or electrocardiographic AF after 12-15 months.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Miguel X. Valderrabano, MD
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) The Methodist Hospital Research Institute The Methodist Hospital System