Vasovagal Syncope Clinical Trial
Official title:
Cardioneuroablation for Neurocardiogenic Syncope
The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the
treatment of neurocardiogenic syncope (NCS), also known as "vaso-vagal" syncope. Syncope is
a general term for passing out spells and neurocardiogenic syncope is a specific form of
passing out spells caused by sudden drops in heart rate or blood pressure. Although the
specific mechanisms of NCS are not well understood, it is believed that some people are
prone to developing passing out spells in specific situations such as standing up for a long
period of time, pain or nausea. In these situations, the body reacts with a paradoxical
reflex which leads to a drop in blood pressure and heart rate and causes passing out.
Certain types of medications are used to treat NCS including beta-blockers, midodrine and
florinef, among others. However, none of these medications are particularly effective at
preventing passing out spells and many people continue to have episodes despite trying
different medications.
Cardioneuroablation is a new form of treatment for NCS. The term ablation means using a wire
to make small electrical burns in the heart. Ablation has been used for many years to treat
other electrical disturbances in the heart but the use of ablation to treat NCS is a new
application. The goal of cardioneuroablation is to identify areas within the heart which are
believed to initiate the reflex which triggers the drop in heart rate and blood pressure
that leads to passing out. In preliminary studies, it has been suggested that
cardioneuroablation may be significantly more effective than medications at preventing
passing out spells for people with NCS.
Hypothesis: Cardioneuroablation of vagal inputs in the left atrium may serve as an effective
treatment modality for the prevention of NCS by blunting the initial trigger of the cascade
that leads to symptoms and syncope.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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