Cardioneuroablation for Neurocardiogenic Syncope (Ablate-NCS)

• ClinicalTrials.gov Identifier: NCT02009982
• Recruitment Status: Completed
• First Posted: December 12, 2013
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016
• Sponsor: David B. De Lurgio
• Collaborator: Biosense Webster, Inc.
• Information provided by (Responsible Party): David B. De Lurgio, Emory University

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.

Condition or disease	Intervention/treatment	Phase
Neurocardiogenic Syncope; Vasovagal Syncope	Procedure: Cardioneuroablation; Device: Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardioneuroablation for Neurocardiogenic Syncope
• Study Start Date: December 2013
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cardioneuroablation; Patients in this group will receive the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter	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
No Intervention: Standard Medical Thearpy; Patients in this group will not receive the cardioneuroablation and will continue to be managed using standard medical therapy

Outcome Measures

Primary Outcome Measures :

1. Syncope Recurrence Rate [ Time Frame: 12 Months ]
   The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol

Secondary Outcome Measures :

1. Incidence of Serious Adverse Events [ Time Frame: 12 Months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

David B. De Lurgio

Biosense Webster, Inc.

Investigators

• Principal Investigator: David B DeLurgio, MD; Emory University

More Information

• Responsible Party: David B. De Lurgio, Associate Professor of Medicine, Emory University
• ClinicalTrials.gov Identifier: NCT02009982
• Other Study ID Numbers: IRB00062061
• First Posted: December 12, 2013
• Results First Posted: November 4, 2016
• Last Update Posted: November 4, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No due to limited data set and study ending.

Keywords provided by David B. De Lurgio, Emory University:

Fainting; Ablation; Cardiology; Cardiac Electrophysiology

Additional relevant MeSH terms:

Syncope; Syncope, Vasovagal; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases