Cardioneuroablation for Neurocardiogenic Syncope (Ablate-NCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
David B. De Lurgio, Emory University
ClinicalTrials.gov Identifier:
NCT02009982
First received: December 9, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention
Neurocardiogenic Syncope
Vasovagal Syncope
Procedure: Cardioneuroablation
Device: Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardioneuroablation for Neurocardiogenic Syncope

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Recurrence of Syncope [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02009982

Contacts
Contact: David B DeLurgio, MD 404-686-2504

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Paige Smith, RN, MS    404-686-7992    pfsmith@emory.edu   
Contact: Mathew Levy, BS    404-686-5974    mrlevy@emory.edu   
Principal Investigator: David B DeLurgio, MD         
Sub-Investigator: Mikhael El Chami, MD         
Sub-Investigator: Michael Lloyd, MD         
Sub-Investigator: Michael Hoskins, MD         
Sub-Investigator: Jonathan Langberg, MD         
Sponsors and Collaborators
David B. De Lurgio
Biosense Webster, Inc.
Investigators
Principal Investigator: David B DeLurgio, MD Emory University
  More Information

No publications provided

Responsible Party: David B. De Lurgio, Associate Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT02009982     History of Changes
Other Study ID Numbers: IRB00062061
Study First Received: December 9, 2013
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Fainting
Ablation
Cardiology
Cardiac Electrophysiology

Additional relevant MeSH terms:
Syncope, Vasovagal
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on September 15, 2014