Status:
NOT_YET_RECRUITING
Tragus Stimulation for POTS Treatment
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Postural Orthostatic Tachycardia Syndrome (POTS)
Eligibility:
All Genders
Phase:
NA
Brief Summary
Postural Tachycardia Syndrome (POTS) is a form of dysautonomia characterized by an abnormal cardiovascular response to orthostatic challenges. Individuals afflicted with POTS typically exhibit a heart...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥18 years
- Diagnosis of POTS, defined as heart rate increase \>30 beats/min from supine within 10 minute of standing, in the absence of orthostatic hypotension (\>20/10 mm Hg fall in blood pressure), with chronic symptoms (\>6 months), and in the absence of other acute causes of orthostatic tachycardia,
- Signed written informed consent by the patient for participation in the study and agreement to comply with the study procedures and the follow-up schedule.
Exclusion
- Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening.
- Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min of standing)
- History or presence of significant neurological, immunological, or hematological disorders
- Cardiovascular disease, such as myocardial infarction within 6 months
- Patients on renal dialysis.
- Life expectancy of \<12 months
- Currently pregnant women or women planning on becoming pregnant ≤ 5 months
- Patients with active implants (such as a cardiac pacemaker, implantable cardioverter-defibrillator, or a cochlear implant)
- Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia.
- Episodic or permanent complete heart block or 2nd degree atrioventricular block Mobitz 2 or bifascicular block with concurrent 1st degree atrioventricular block
- Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)
- Inability to comply with the protocol.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07163130
Start Date
September 1 2025
End Date
January 31 2027
Last Update
September 9 2025
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