Atrial FibrillationNCT03533140
Postoperative Atrial Fibrillation Suppression By Nerve Stimulation
A study testing DUCEST Neurostimulator V Group A and DUCEST Neurostimulator V Group B in people with Atrial Fibrillation, run by Medical University of Vienna.
Trial summary
The current study will evaluate the potential of stimulating the R.auricularis of the vagus nerve located at the Fossa triangularis to ameliorate or suppress AF in the study Population! Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- DUCEST Neurostimulator V Group A and DUCEST Neurostimulator V Group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 31 May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De-novo postoperative AF
- CABG or aortic valve replacement
- Age of 18-80 years
- Willing and able to understand, sign and date the informed consent form that has been approved by the institutional review board
Who cannot join
- Pacemaker or ICD
- Impaired EF < 30%
- Patients with acute myocardial infarction within the past 14 days
- Pregnant or lactating patients
- Any condition that, in the judgement of the investigator, would place the patient at undue risk
- Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study
- Treatment and/or an uncompleted follow-up treatment of any investigational therapy within 6 months before procedure and intent to participate in any other investigational drug or cell therapy study during the follow-up period of this study
- Active participation in other Research therapy for cardiovascular repair/regeneration
About this study
Official title: Low Level Transcutaneous Electrical Vagus Nerve Stimulation To Suppress Atrial Fibrillation
The current study will evaluate the potential of stimulating the R.auricularis of the vagus nerve located at the Fossa triangularis to ameliorate or suppress AF in the study Population!
Read the detailed description
Scientific Background Nearly 30% of patients undergoing coronary artery bypass grafting (CABG), 40% of patients undergoing valvular heart surgery and over 50% of patients with combined coronary and valvular procedures develop atrial fibrillation (AF).
Postoperative AF occurs mostly due to conditions like chronic kidney diseases, emergency surgery, age >75 years, cardiopulmonary bypass time >180 min and due to lacking postoperative application of aldosterone- and beta-blockers.
An overview of pre- intra- and postoperative risks for AF is listed in
Table 1: Pre-, intra-, postoperative risks for AF.
Preoperative High age Male gender Previous cardiac surgery Valvular heart disease Chronic lung disease Chronic renal failure Leſt atrium enlargement Leſt ventricular hypertrophy Withdrawal of beta-blocker medication History of AF Hypertension Obesity Diabetes Metabolic Syndrome
Intraoperative Endotracheal tube insertion Intraoperative IABP Leſt ventricular venting Aortic cross-clamp time Extracorporeal circulation Myocardial ischemia Venous cannulation Damage to the atrium Excess inotropic requirements Acute volume change
Postoperative Return to intensive care unit Ventilation longer than 24 hours Volume overload Pneumonia Electrolyte imbalances Imbalance of auton. nervous system Atrial extrasystole Increased postop adrenergic status Increased aſterload Inflammation Hypotension
Several theories describe the emergence of AF like "multiple-wavelet re-entry", "focal mechanism" and "mother rotor" but the exact underlying mechanisms are still not well understood.
Prevention and treatment of postoperative AF are managed with conservative medication therapies including e.g. beta-blockers and other clinical interventions include radio frequency catheter ablation, cardioversion and occlusion of the left atrial appendage.
A novel approach for suppression of AF utilizing low-level transcutaneous electrical vagus nerve stimulation has been described recently in the Journal of the American College of Cardiology. The newly developed "DUCEST Neurostimulator V" device (manufactured by Biegler Medizinelektronik GmbH Mauerbach, Austria) offers similar action as in. This Neurostimulator device is designed to emit small direct current electrical pulses (0-1,2mA) to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. The target population are patients with de-novo postoperative AF. The stimulation is achieved with the attachment of two needle- electrodes and connection of the electrodes to the Neurostimulator.
Following the stimulation of the vagus nerve positive effects were already achieved in chronical wound healing, peripheral artery occlusive disease (PAOD), Claudicatio intermittens (CI) and chronic pain patients.
- Conditions
- Atrial Fibrillation
- Being tested
- DUCEST Neurostimulator V Group A, DUCEST Neurostimulator V Group B
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUCEST Neurostimulator V Group ADevice
The DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. The built-in 3V battery lasts for approx. 14 days. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed.
DUCEST Neurostimulator V Group BDevice
The DUCEST Neurostimulator V needle-electrodes are applied post-operatively at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates only the signal lamp but not the device.
| Study group | Role | What they receive |
|---|---|---|
| DUCEST Neurostimulator V Group A | Active comparator | Not described Receives: Device: DUCEST Neurostimulator V Group A |
| DUCEST Neurostimulator V Group B | Sham comparator | Not described Receives: Device: DUCEST Neurostimulator V Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay.
Patients are randomized to a treatment or a sham group. The corresponding device is prepared by a third person according to the double-blind setting for the surgeon. The DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed.
Measured: 07-14 days post operative
Secondary outcomes (1)
Measurement of postoperative inflammation markes, using plasma values of CRP, TNF-alpha, IL-6, and IL-10
Inflammation markers will be assessed via laboratory blood sample testing at day 0 (at device attachment), +2 and +7 days post device attachment. CRP, TNF-alpha, IL-6, and IL-10 will be will be measured.
Measured: 07-14 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Oct 2015
- Primary completion1 Mar 2018
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfred A Kocher, MD, Medical University of Vienna
- Investigators
- Alfred Kocher, MD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533140
- Sponsor's protocol ID
- 1 KlinPruefplanProtocol6
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 23 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Transcutaneous Electrical Vagus Nerve Stimulation To Suppress Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03533140
- Acronym / sponsor ID
- 1 KlinPruefplanProtocol6
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 23 May 2018 (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.
The current study will evaluate the potential of stimulating the R.auricularis of the vagus nerve located at the Fossa triangularis to ameliorate or suppress AF in the study Population!
Detailed description
Scientific Background Nearly 30% of patients undergoing coronary artery bypass grafting (CABG), 40% of patients undergoing valvular heart surgery and over 50% of patients with combined coronary and valvular procedures develop atrial fibrillation (AF).
Postoperative AF occurs mostly due to conditions like chronic kidney diseases, emergency surgery, age >75 years, cardiopulmonary bypass time >180 min and due to lacking postoperative application of aldosterone- and beta-blockers.
An overview of pre- intra- and postoperative risks for AF is listed in
Table 1: Pre-, intra-, postoperative risks for AF.
Preoperative High age Male gender Previous cardiac surgery Valvular heart disease Chronic lung disease Chronic renal failure Leſt atrium enlargement Leſt ventricular hypertrophy Withdrawal of beta-blocker medication History of AF Hypertension Obesity Diabetes Metabolic Syndrome
Intraoperative Endotracheal tube insertion Intraoperative IABP Leſt ventricular venting Aortic cross-clamp time Extracorporeal circulation Myocardial ischemia Venous cannulation Damage to the atrium Excess inotropic requirements Acute volume change
Postoperative Return to intensive care unit Ventilation longer than 24 hours Volume overload Pneumonia Electrolyte imbalances Imbalance of auton. nervous system Atrial extrasystole Increased postop adrenergic status Increased aſterload Inflammation Hypotension
Several theories describe the emergence of AF like "multiple-wavelet re-entry", "focal mechanism" and "mother rotor" but the exact underlying mechanisms are still not well understood.
Prevention and treatment of postoperative AF are managed with conservative medication therapies including e.g. beta-blockers and other clinical interventions include radio frequency catheter ablation, cardioversion and occlusion of the left atrial appendage.
A novel approach for suppression of AF utilizing low-level transcutaneous electrical vagus nerve stimulation has been described recently in the Journal of the American College of Cardiology. The newly developed "DUCEST Neurostimulator V" device (manufactured by Biegler Medizinelektronik GmbH Mauerbach, Austria) offers similar action as in. This Neurostimulator device is designed to emit small direct current electrical pulses (0-1,2mA) to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. The target population are patients with de-novo postoperative AF. The stimulation is achieved with the attachment of two needle- electrodes and connection of the electrodes to the Neurostimulator.
Following the stimulation of the vagus nerve positive effects were already achieved in chronical wound healing, peripheral artery occlusive disease (PAOD), Claudicatio intermittens (CI) and chronic pain patients.
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 |
|---|---|---|
| DUCEST Neurostimulator V Group A | Active comparator | Device: DUCEST Neurostimulator V Group A |
| DUCEST Neurostimulator V Group B | Sham comparator | Device: DUCEST Neurostimulator V Group B |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- De-novo postoperative AF
- CABG or aortic valve replacement
- Age of 18-80 years
- Willing and able to understand, sign and date the informed consent form that has been approved by the institutional review board
Key exclusion criteria (8 listed)
- Pacemaker or ICD
- Impaired EF < 30%
- Patients with acute myocardial infarction within the past 14 days
- Pregnant or lactating patients
- Any condition that, in the judgement of the investigator, would place the patient at undue risk
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 |
|---|---|---|
| DUCEST Neurostimulator V Group AThe DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. The built-in 3V battery lasts for approx. 14 days. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed. | Device | DUCEST Neurostimulator V Group A |
| DUCEST Neurostimulator V Group BThe DUCEST Neurostimulator V needle-electrodes are applied post-operatively at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates only the signal lamp but not the device. | Device | DUCEST Neurostimulator V Group B |
Primary outcome
Incidence of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay.
Time frame: 07-14 days post operative
Patients are randomized to a treatment or a sham group. The corresponding device is prepared by a third person according to the double-blind setting for the surgeon. The DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed.
1 secondary outcome
Measurement of postoperative inflammation markes, using plasma values of CRP, TNF-alpha, IL-6, and IL-10
Time frame: 07-14 days post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- 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.
Alfred Kocher, MD principal investigator
Surgeon
Questions about this trial
What is this clinical trial studying?
A study testing DUCEST Neurostimulator V Group A and DUCEST Neurostimulator V Group B in people with Atrial Fibrillation, run by Medical University of Vienna.
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 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: status not confirmed, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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 of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay. (time frame: 07-14 days post operative). 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 23 May 2018.