Neurocardiogenic SyncopeAblate-NCSNCT02009982
Cardioneuroablation for Neurocardiogenic Syncope
A study testing Cardioneuroablation and Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter in people with Neurocardiogenic Syncope and Vasovagal Syncope, run by David B. De Lurgio at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurocardiogenic Syncope, Vasovagal Syncope
- What is being tested?
- Cardioneuroablation and Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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
- Being tested
- Cardioneuroablation, Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
- Keywords
- Fainting, Ablation, Cardiology, Cardiac Electrophysiology
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioneuroablationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Cardioneuroablation | Experimental | Patients in this group will receive the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter Receives: Procedure: Cardioneuroablation; Device: Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter |
| Standard Medical Thearpy | No intervention | Patients in this group will not receive the cardioneuroablation and will continue to be managed using standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncope Recurrence Rate
The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol
Measured: 12 Months
Secondary outcomes (1)
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurocardiogenic SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- David B. De Lurgio
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, David B. De Lurgio, Emory University
- Investigators
- David B DeLurgio, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009982
- Sponsor's protocol ID
- IRB00062061
- Acronym
- Ablate-NCS
- Status last verified
- Sep 2016
- First submitted
- 9 Dec 2013
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No due to limited data set and study ending.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioneuroablation for Neurocardiogenic Syncope
- ClinicalTrials.gov ID
- NCT02009982
- Acronym / sponsor ID
- Ablate-NCS / IRB00062061
- Conditions
- Neurocardiogenic Syncope, Vasovagal Syncope
- Keywords
- Fainting, Ablation, Cardiology, Cardiac Electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- David B. De LurgioUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 4 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardioneuroablation | Experimental | Procedure: Cardioneuroablation, Device: Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip CatheterPatients in this group will receive the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter |
| Standard Medical Thearpy | No intervention | –Patients in this group will not receive the cardioneuroablation and will continue to be managed using standard medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioneuroablationCatheter Ablation of Vagal Inputs in Left Atrium | Procedure or surgery | Cardioneuroablation |
| Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip CatheterThis is the device that will be used to perform the Cardioneuroablation procedure | Device | Cardioneuroablation |
Primary outcome
Syncope Recurrence Rate
Time frame: 12 Months
The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol
1 secondary outcome
Incidence of Serious Adverse Events
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No due to limited data set and study ending.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B DeLurgio, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardioneuroablation and Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter in people with Neurocardiogenic Syncope and Vasovagal Syncope, run by David B. De Lurgio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syncope Recurrence Rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.