Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure

NACompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 1, 2014

Primary Completion Date

January 31, 2016

Study Completion Date

January 31, 2016

Conditions
Chronic Heart Failure
Interventions
DEVICE

P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance

P-STIM (Biegler, Mauerbach, Austria) is a battery-operated micro-stimulation appliance weighing 5 grams, designed as a disposable product for a single use. P-STIM is placed behind the patient's ear and connected to stimulation needles (usually 3 needles) on the auricle. For the study, only one stimulation needle was needed. P-STIMTM offers regular therapy over several days. The appliance transmits low frequency electric pulses to exposed nerve endings. The built-in microchip creates periods of stimulation and rest, each lasting approximately 3 hours. Stimulation was performed with a frequency of 1Hz for 40min followed by a break of 20 min.

DEVICE

Placebo

The placebo device is a look-a-like, that stimulates only for 1h hour and then stops.

Trial Locations (1)

1090

Medical University of Vienna, Vienna

All Listed Sponsors
lead

Medical University of Vienna

OTHER

NCT06950320 - Clinical Outcome of Electrical Transcutaneous Auricular Vagal Stimulation in Patients With Stable Symptomatic Chronic Heart Failure | Biotech Hunter | Biotech Hunter