Transcutaneous Vagal Nerve Stimulation for the Treatment of Persistent Atrial Fibrillation (VAST-AF): a Randomized, Controlled, Blinded, Monocentric, Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this clinical trial is to answer the question whether a transcutaneous stimulation of a certain nerve (Nervus vagus) with a dedicated device reduces the recurrence of the heart rhythm disorder atrial fibrillation. Participants will receive a dedicated nerval stimulation device and will treat themselves on a daily basis for at least an hour per day. Treatment will last for 3 months. Researchers will compare this group with a similar group that uses an ineffective device. Both researcher and patients will be blinded so they do not know which device they will be using.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Persistent atrial fibrillation
• Planned electric cardioversion
• Sufficient oral anticoagulation for at least four weeks or
• Absence of thrombus in transoesophageal echocardiography
• Oral anticoagulation possible
• Able to sign informed consent
• Estimated life expectancy \>1 year
Locations
Other Locations
Germany
Marienhaus Klinikum Hetzelstift
RECRUITING
Neustadt
Contact Information
Primary
Patrick Swojanowsky, MD
patrick.swojanowsky@marienhaus.de
+4906321/859-4001
Backup
Hubertus von Korn, PhD
hubertus.vonkorn@marienhaus.de
+4906321/859-4001
Time Frame
Start Date:2023-11-06
Estimated Completion Date:2025-12-20
Participants
Target number of participants:120
Treatments
Experimental: Verum group
Verum group - active vagal stimulation with the stimulation device tVNS from tVNS Technologies GmbH. The stimulation is performed with an ear-electrode at the Tragus. Minimal stimulation duration is 1 hour per day for 3 months.
Sham_comparator: Sham group
Sham group with ineffective vagal stimulation. Same stimulation procedure like in the verum group with the stimulation device tVNS from tVNS Technologies GmbH. The stimulation is performed with an ear-electrode at the Tragus, too. Minimal stimulation duration is 1 hour per day for 3 months, but with a non conducting ear electrode.