Postoperative Atrial Fibrillation Suppression By Nerve Stimulation

NCT03533140 | Unknown

• 1 other identifier: 1 KlinPruefplanProtocol6
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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!

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  07-14 days post operative

Study Arms (2)

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

Interventions

DUCEST Neurostimulator V Group A DEVICE

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 A

DUCEST Neurostimulator V Group B DEVICE

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.

DUCEST Neurostimulator V Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfred Kocher, MD

  Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: May 31, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share