Atrial Fibrillation, PostoperativeTON-POINTSNCT02783157
Transcutaneous Autonomic Modulation in Thoracic Surgery
A study testing Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) in people with Atrial Fibrillation, Postoperative and Postoperative Complications, run by Duke University at 1 site in United States.
Trial summary
In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Atrial Fibrillation, Postoperative, Postoperative Complications, Inflammation
- What is being tested?
- Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 21 Feb 2020
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)
Who cannot join
- Patients >90 or <40 years of age
- Chronic atrial fibrillation
- Prior splenectomy
- Preoperative inotropic support
- Hepatic or renal failure
- Currently receiving vagal nerve stimulation therapy
- Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine)
- High-grade atrioventricular block (>2nd degree atrioventricular blockade)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.
- Being tested
- Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS), Sham LLVNS
- Keywords
- Autonomic, Vagal nerve stimulation, Postoperative atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Postoperative Complications, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)Device
Low-level vagal nerve stimulation will be delivered via a clip applied to the ear throughout the surgical procedure. The voltage used will be individualized to each patient, based upon the voltage necessary to slow the sinus rate during testing.
Sham LLVNSDevice
A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous low-level vagal nerve stimulation (LLVNS) | Experimental | n=100 patients will be randomized to transcutaneous low-level vagal nerve stimulation (LLVNS), via a clip applied to the ear. Stimulation will be delivered throughout the procedure. Receives: Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) |
| Sham LLVNS | Sham comparator | n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered. Receives: Device: Sham LLVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/Burden of Postoperative Atrial Fibrillation
Measured: Inpatient hospitalization approximately 3 to 7 days
Secondary outcomes (3)
Postoperative morbidity
The incidence of complications during the index hospitalization and one year after surgery
Measured: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Postoperative mortality
The incidence of complications during the index hospitalization and one year after surgery
Measured: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Serologic Markers of Inflammation
Cytokine levels, measured in pg/mL
Measured: Inpatient hospitalization approximately 3 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startMay 2016
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
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 Atrial Fibrillation, PostoperativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph P Mathew, MD, MHS, MBA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783157
- Sponsor's protocol ID
- Pro00071148
- Acronym
- TON-POINTS
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2016
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026.
PubMed 25744003
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Autonomic Modulation to Prevent Organ Injury After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02783157
- Acronym / sponsor ID
- TON-POINTS / Pro00071148
- Keywords
- Autonomic, Vagal nerve stimulation, Postoperative atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 26 May 2016 (estimated)
- 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.
In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous low-level vagal nerve stimulation (LLVNS) | Experimental | Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)n=100 patients will be randomized to transcutaneous low-level vagal nerve stimulation (LLVNS), via a clip applied to the ear. Stimulation will be delivered throughout the procedure. |
| Sham LLVNS | Sham comparator | Device: Sham LLVNSn=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)
Key exclusion criteria (8 listed)
- Patients >90 or <40 years of age
- Chronic atrial fibrillation
- Prior splenectomy
- Preoperative inotropic support
- Hepatic or renal failure
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 |
|---|---|---|
| Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)Low-level vagal nerve stimulation will be delivered via a clip applied to the ear throughout the surgical procedure. The voltage used will be individualized to each patient, based upon the voltage necessary to slow the sinus rate during testing. | Device | Transcutaneous low-level vagal nerve stimulation (LLVNS) |
| Sham LLVNSA clip will be applied to the ear, but no stimulation will be delivered throughout the procedure. | Device | Sham LLVNS |
Primary outcome
Incidence/Burden of Postoperative Atrial Fibrillation
Time frame: Inpatient hospitalization approximately 3 to 7 days
3 secondary outcomes
Postoperative morbidity
Time frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Postoperative mortality
Time frame: Inpatient hospitalization approximately 3 to 7 days, and one year after surgery
Serologic Markers of Inflammation
Time frame: Inpatient hospitalization approximately 3 to 7 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Background: PubMed 25744003Stavrakis S, Humphrey MB, Scherlag BJ, Hu Y, Jackman WM, Nakagawa H, Lockwood D, Lazzara R, Po SS. Low-level transcutaneous electrical vagus nerve stimulation suppresses atrial fibrillation. J Am Coll Cardiol. 2015 Mar 10;65(9):867-75. doi: 10.1016/j.jacc.2014.12.026.
- Individual participant dataSharing planned: Undecided
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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.
Joseph P Mathew, MD, MHS, MBA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS) in people with Atrial Fibrillation, Postoperative and Postoperative Complications, run by Duke University 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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Apr 2020. 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. Some participants in this study may receive a placebo. 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 was stopped early. Results are not available in the source record.
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?
Incidence/Burden of Postoperative Atrial Fibrillation (time frame: Inpatient hospitalization approximately 3 to 7 days). 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 NCT02783157, 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 6 Apr 2020.