Postoperative Atrial Fibrillation Suppression By Nerve Stimulation
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DUCEST Neurostimulator V Group A
DUCEST Neurostimulator V Group B
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
DUCEST Neurostimulator V Group A
DUCEST Neurostimulator V Group B
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03533140
First Posted
April 26, 2018
Last Updated
May 9, 2018
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT03533140
Brief Title
Postoperative Atrial Fibrillation Suppression By Nerve Stimulation
Official Title
Low Level Transcutaneous Electrical Vagus Nerve Stimulation To Suppress Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
May 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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!
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DUCEST Neurostimulator V Group A
Arm Type
Active Comparator
Arm Title
DUCEST Neurostimulator V Group B
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
DUCEST Neurostimulator V Group A
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
DUCEST Neurostimulator V Group B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay.
Description
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.
Time Frame
07-14 days post operative
Secondary Outcome Measure Information:
Title
Measurement of postoperative inflammation markes, using plasma values of CRP, TNF-alpha, IL-6, and IL-10
Description
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.
Time Frame
07-14 days post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Kocher, MD
Organizational Affiliation
Surgeon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Postoperative Atrial Fibrillation Suppression By Nerve Stimulation
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