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Cardioneuroablation for Neurocardiogenic Syncope (Ablate-NCS)

Primary Purpose

Neurocardiogenic Syncope, Vasovagal Syncope

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cardioneuroablation

Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

About this trial

This is an interventional treatment trial for Neurocardiogenic Syncope focused on measuring Fainting, Ablation, Cardiology, Cardiac Electrophysiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is able and willing to sign and date the Patient Consent Form
Subject is 18 years of age or older
Subject is expected to remain available for the follow-up protocol
Subject is willing to comply with the follow-up procedures
Subject has medically documented history of neurocardiogenic syncope
Subject has had 3 episodes of syncope or presyncope in last 12 months
Subject has had a positive tilt table test, defined as the presence of syncope or presyncope associated with abrupt hypotension (SBP < 70 mmHg) or bradycardia (HR < 40 bpm), with or without sublingual nitroglycerin provocation or atropine challenge
Subject has been tried on at least one pharmacologic therapy for at least 4 weeks

Exclusion Criteria:

Subject has signs and symptoms of an active infection (i.e. fever, elevated white blood cell count, etc.) which has not been treated and/or has not demonstrated improvement in white blood cell count and resolution of fever
Subject is pregnant or planning to become pregnant within the study protocol follow-up
Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician
Subject is unwillingly to comply with the randomization procedure
Subject has had no syncopal episodes in last six months while on medical therapy
Subject has one of the following conditions that is the documented source of syncope: sick sinus syndrome, sinus node or atrioventricular conduction deficiencies, ventricular tachyarrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, history of transient ischemic attack, seizure disorders, subclavian steal syndrome, or drug-induced syncope
Subjects with a myocardial infarction within last six months
Subjects with severe heart failure (NYHA class III or IV), previous heart surgery, structural heart disease, or an infiltrative cardiac disease
Subject is contraindicated for left-atrial ablation, as determined by enrolling physician

Sites / Locations

Emory University
University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardioneuroablation

Standard Medical Thearpy

Arm Description

Patients in this group will receive the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

Patients in this group will not receive the cardioneuroablation and will continue to be managed using standard medical therapy

Outcomes

Primary Outcome Measures

Syncope Recurrence Rate

The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol

Secondary Outcome Measures

Incidence of Serious Adverse Events

The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol

Full Information

NCT ID

NCT02009982

First Posted

December 9, 2013

Last Updated

September 16, 2016

Sponsor

David B. De Lurgio

Collaborators

Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02009982

Brief Title

Cardioneuroablation for Neurocardiogenic Syncope

Acronym

Ablate-NCS

Official Title

Cardioneuroablation for Neurocardiogenic Syncope

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David B. De Lurgio

Collaborators

Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurocardiogenic Syncope, Vasovagal Syncope

Keywords

Fainting, Ablation, Cardiology, Cardiac Electrophysiology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardioneuroablation

Arm Type

Experimental

Arm Description

Patients in this group will receive the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

Arm Title

Standard Medical Thearpy

Arm Type

No Intervention

Arm Description

Patients in this group will not receive the cardioneuroablation and will continue to be managed using standard medical therapy

Intervention Type

Procedure

Intervention Name(s)

Cardioneuroablation

Intervention Description

Catheter Ablation of Vagal Inputs in Left Atrium

Intervention Type

Device

Intervention Name(s)

Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

Intervention Description

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

Primary Outcome Measure Information:

Title

Syncope Recurrence Rate

Description

The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Incidence of Serious Adverse Events

Description

The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able and willing to sign and date the Patient Consent Form Subject is 18 years of age or older Subject is expected to remain available for the follow-up protocol Subject is willing to comply with the follow-up procedures Subject has medically documented history of neurocardiogenic syncope Subject has had 3 episodes of syncope or presyncope in last 12 months Subject has had a positive tilt table test, defined as the presence of syncope or presyncope associated with abrupt hypotension (SBP < 70 mmHg) or bradycardia (HR < 40 bpm), with or without sublingual nitroglycerin provocation or atropine challenge Subject has been tried on at least one pharmacologic therapy for at least 4 weeks Exclusion Criteria: Subject has signs and symptoms of an active infection (i.e. fever, elevated white blood cell count, etc.) which has not been treated and/or has not demonstrated improvement in white blood cell count and resolution of fever Subject is pregnant or planning to become pregnant within the study protocol follow-up Subject is enrolled or planning to participate in a concurrent drug and/or device study during the course of this study that would confound study results as determined by the study physician Subject is unwillingly to comply with the randomization procedure Subject has had no syncopal episodes in last six months while on medical therapy Subject has one of the following conditions that is the documented source of syncope: sick sinus syndrome, sinus node or atrioventricular conduction deficiencies, ventricular tachyarrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, history of transient ischemic attack, seizure disorders, subclavian steal syndrome, or drug-induced syncope Subjects with a myocardial infarction within last six months Subjects with severe heart failure (NYHA class III or IV), previous heart surgery, structural heart disease, or an infiltrative cardiac disease Subject is contraindicated for left-atrial ablation, as determined by enrolling physician

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David B DeLurgio, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No due to limited data set and study ending.

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Cardioneuroablation for Neurocardiogenic Syncope

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