Clinical trials: Neurally Mediated Syncope
Vasovagal Syncope
Syncope Prediction Study
The purpose of this study is to perform a prospective evaluation of the vasovagal syncope prediction algorithm, called Tilt Test Analyzer, during head up tilt testing tests in one center in the United Kingdom.
- Trial name
- SPS (NCT02140567)
- Where
- United Kingdom
- Volunteers
- 140 people
- Sponsor
- Medtronic BRC
Syncope, Vasovagal, Neurally-Mediated
Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin.
- Trial name
- NCT06697145
- Testing
- Cardioneuroablation
- Where
- Poland
- Volunteers
- 12 people
- Sponsor
- Wroclaw Medical University
Syncope
Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope
The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences.
- Trial name
- BIOSync CLS (NCT02324920)
- Testing
- DDD-CLS, ODO
- Where
- 24 sites in Canada, France and 4 more
- Volunteers
- 128 people
- Sponsor
- Biotronik SE & Co. KG
Reflex Syncope
Implantable Loop Recorder and Cardioneuroblation
The study aims to determine which method of vagal ganglia ablation is most effective in preventing recurrences of reflex asystole syncope.
- Trial name
- ILR-CNA (NCT07162740)
- Testing
- Right atrial ablation, Bi-atrial ablation
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Auxologico Italiano
Arhythmia, Atrioventricular Heart-block
Observation of ImageReady™ MR Conditional Pacing System in China
To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects
- Conditions
- Arhythmia, Atrioventricular Heart-block, Chronic Bundle Branch or Branch Block, Carotid Sinus Hypersensitivity Reaction Syndrome
- Trial name
- NCT02636712
- Testing
- ImageReady™ MR Conditional Pacing System
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Boston Scientific Corporation
Syncope
International Study on Syncope of Uncertain Etiology
This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loop Recorder (ILR)implantation.
- Trial name
- NCT00120094
- Where
- 3 sites in Italy, United Kingdom
- Volunteers
- 400 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Reflex Syncope
Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness.
- Trial name
- PANACEA (NCT05855603)
- Testing
- Cardioneuroablation, Permanent pacemaker therapy
- Where
- 10 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Institut d'Investigació Biomèdica de Bellvitge
Vasovagal Syncope, Postural Tachycardia Syndrome
Hypnosis in Autonomic Function
This study will investigate the relationship between susceptibility to hypnosis and regulation of the autonomic nervous system (nerves that control involuntary body functions, such as heart rate and sweating).
- Conditions
- Vasovagal Syncope, Postural Tachycardia Syndrome, Hypnosis
- Trial name
- NCT00061009
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Vasovagal Syncope
Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope
Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.
- Trial name
- POST6 (NCT02500732)
- Testing
- Atomoxetine
- Where
- Canada
- Volunteers
- 57 people
- Sponsor
- University of Calgary
Orthostatic Hypotension, Syncope
The Effect of Water Carbonation on Orthostatic Tolerance
The primary purpose of this investigation is to determine whether water carbonation can improve orthostatic tolerance in healthy control volunteers.
- Conditions
- Orthostatic Hypotension, Syncope, Vasovagal Syncope
- Trial name
- NCT05621460
- Testing
- 500mL carbonated water, 500mL still water, 50mL still water
- Where
- Canada
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Simon Fraser University
Syncope, Vasovagal
Cardioneuroablation and Ventricular Proarrhythmia
Cardioneuroablation (CNA) is a promising tool to treat patients with asystolic reflex syncope. CNA acts through complete or near complete abolition of vagal nerve chronotropic and dromotropic effects on the heart, resulting in…
- Trial name
- Roman4 (NCT06458140)
- Testing
- Cardioneuroablation
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Centre of Postgraduate Medical Education
Hypotensive Syncope
Stop Vasodepressor Drugs in Reflex Syncope
Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.
- Trial name
- STOP-VD (NCT02137278)
- Testing
- Vasoactive drug therapies, Stop/reduce vasoactive drugs
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Cardiac Pacemaker, Arrythmia
Aveir DR Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Trial name
- NCT05935007
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- United States
- Volunteers
- 1,805 people
- Sponsor
- Abbott Medical Devices
Syncope, Vasovagal
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery.
- Trial name
- NCT04972123
- Testing
- CPC - Capsaicin, Phenylephrine, Caffeine, Tilt Table Test
- Where
- United States
- Volunteers
- 143 people
- Sponsor
- University of Wisconsin, Madison
Neurocardiogenic Syncope, Vasovagal Syncope
Cardioneuroablation for Neurocardiogenic Syncope
The purpose of this study is to evaluate the effectiveness of cardioneuroablation for the treatment of neurocardiogenic syncope (NCS), also known as "vaso-vagal" syncope.
- Trial name
- Ablate-NCS (NCT02009982)
- Testing
- Cardioneuroablation, Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- David B. De Lurgio
Vasovagal Syncope
Study of Atomoxetine in the Prevention of Vasovagal Syncope
Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical…
- Trial name
- POST7 (NCT05159687)
- Testing
- Atomoxetine Hydrochloride
- Where
- Canada
- Volunteers
- 180 people
- Sponsor
- University of Calgary
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Reducing Orthostatic Intolerance With Oral Rehydration in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients
We and others have shown that many younger patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have orthostatic intolerance (OI), i.e., they can't tolerate prolonged standing.
- Conditions
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Systemic Exertion Intolerance Disease (SEID), Postural Tachycardia Syndrome (POTS)
- Trial name
- NCT02854683
- Testing
- Normal Saline, Oral Rehydration Solution
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- New York Medical College
Dysautonomia
MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters
The purpose of this research study is to better understand what causes dysautonomia and how this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous system.
- Trial name
- NCT01692561
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Vasovagal Syncope
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
The main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia.
- Trial name
- NCT00292825
- Testing
- Pacemaker treatment, pacemaker programmed as active = CLS, Pacemaker, programmed as passive = VVI 30 beats per minute (bpm)
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aarhus University Hospital Skejby
Syncope
Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope
OBJECTIVES: Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.
- Trial name
- NCT00004479
- Testing
- midodrine
- Where
- United States
- Sponsor
- Icahn School of Medicine at Mount Sinai