ArrhythmiaNCT04359004
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation
A study testing Vagus Nerve Stimulation (VNS) in people with Arrhythmia and Ventricular Tachycardia (VT), run by University of California, Los Angeles at 1 site in United States.
Trial summary
Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Ventricular Tachycardia (VT)
- What is being tested?
- Vagus Nerve Stimulation (VNS)
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- Age > 18 years old
- Underlying sinus rhythm with heart rate > 50 bpm.
- Provision of signed/dated informed consent and stated willingness to comply with all study procedures
Who cannot join
- Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
- Status post orthotopic heart transplantation
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Unable or unwilling to comply with protocol requirements.
- Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
- Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
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- New York Heart Association Class IV heart failure or use of current vasopressor medications
- Incessant VT
- Persistent atrial fibrillation
- Frequent premature atrial or ventricular contractions
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation
Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.
Read the detailed description
This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.
- Conditions
- Arrhythmia, Ventricular Tachycardia (VT)
- Being tested
- Vagus Nerve Stimulation (VNS)
- Keywords
- Arrhythmia, Vagus Nerve Stimulation (VNS), Activation Recovery Interval (ARI)
- Medical subject headings
- Arrhythmias, Cardiac, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation (VNS)Other
Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded.
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in ventricular action potential duration during stimulation compared to baseline in msec
Measured: Up to 30 minutes or completion of the vagus nerve stimulation
Secondary outcomes (2)
The change in blood pressure during stimulation compared to baseline in mmHg.
Measured: Up to 30 minutes or completion of the vagus nerve stimulation
The change in heart rate during stimulation compared to baseline in beats per minute
Measured: Up to 30 minutes or completion of the vagus nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kalyanam Shivkumar, MD, PhD, University of California, Los Angeles
- Investigators
- Kalyanam Shivkumar, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359004
- Sponsor's protocol ID
- 19-001929
- Other IDs
- OT2OD028201
- Status last verified
- Nov 2023
- First submitted
- 16 Apr 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.
PubMed 28814663
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing Ventricular Tachycardia (VT) Ablation
- ClinicalTrials.gov ID
- NCT04359004
- Acronym / sponsor ID
- 19-001929
- Conditions
- Arrhythmia, Ventricular Tachycardia (VT)
- Keywords
- Arrhythmia, Vagus Nerve Stimulation (VNS), Activation Recovery Interval (ARI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.
Detailed description
This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
- Age > 18 years old
- Underlying sinus rhythm with heart rate > 50 bpm.
- Provision of signed/dated informed consent and stated willingness to comply with all study procedures
Key exclusion criteria (11 listed)
- Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
- Status post orthotopic heart transplantation
- Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
- Unable or unwilling to comply with protocol requirements.
- Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
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 |
|---|---|---|
| Vagus Nerve Stimulation (VNS)Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded. | Other | – |
Primary outcome
The change in ventricular action potential duration during stimulation compared to baseline in msec
Time frame: Up to 30 minutes or completion of the vagus nerve stimulation
2 secondary outcomes
The change in blood pressure during stimulation compared to baseline in mmHg.
Time frame: Up to 30 minutes or completion of the vagus nerve stimulation
The change in heart rate during stimulation compared to baseline in beats per minute
Time frame: Up to 30 minutes or completion of the vagus nerve stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 28814663Vaseghi M, Salavatian S, Rajendran PS, Yagishita D, Woodward WR, Hamon D, Yamakawa K, Irie T, Habecker BA, Shivkumar K. Parasympathetic dysfunction and antiarrhythmic effect of vagal nerve stimulation following myocardial infarction. JCI Insight. 2017 Aug 17;2(16):e86715. doi: 10.1172/jci.insight.86715. eCollection 2017 Aug 17.
- Individual participant dataSharing planned: No
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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.
Kalyanam Shivkumar, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation (VNS) in people with Arrhythmia and Ventricular Tachycardia (VT), run by University of California, Los Angeles at 1 site 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 4 inclusion and 11 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in ventricular action potential duration during stimulation compared to baseline in msec (time frame: Up to 30 minutes or completion of the vagus nerve stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359004, which also lists 1 linked publication.
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 13 Nov 2023.