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Cardioneuroablation for Neurocardiogenic Syncope

NCT02009982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-11-04

Study results available
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Summary

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.

Conditions

  • Neurocardiogenic Syncope
  • Vasovagal Syncope

Interventions

PROCEDURE

Cardioneuroablation

Catheter Ablation of Vagal Inputs in Left Atrium

DEVICE

Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

This is the device that will be used to perform the Cardioneuroablation procedure

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • David B. De Lurgio

    lead OTHER

Principal Investigators

  • David B DeLurgio, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02009982 on ClinicalTrials.gov