CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3 enrolled
Drug / intervention
Cardioneuroablation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02009982
NCT02009982N/ACompleted

Cardioneuroablation for Neurocardiogenic Syncope

David B. De Lurgio·interventional·Posted Dec 12, 2013·Updated Nov 4, 2016

In Brief

A clinical study evaluating Cardioneuroablation and Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter for Neurocardiogenic Syncope and Vasovagal Syncope. Completed, enrolled 3 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 12, 2013
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.6 years ago

Interventions

Cardioneuroablationprocedure

Catheter Ablation of Vagal Inputs in Left Atrium

Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheterdevice

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