Clinical trials: Unconscious
Syncope, Palpitations
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days…
- Trial name
- ITHO04 (NCT02253134)
- Where
- 10 sites in Belgium, Italy and 3 more
- Volunteers
- 395 people
- Sponsor
- LivaNova
Tachyarrhythmia, Atrial Fibrillation (AF)
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk…
- Conditions
- Tachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
- Trial name
- NCT04025710
- Testing
- BIOMONITOR III and BIOMONITOR IIIm
- Where
- 27 sites in Australia, Austria and 4 more
- Volunteers
- 167 people
- Sponsor
- Biotronik SE & Co. KG
Hypoglycemia Unawareness, Diabetes Mellitus, Type 1
Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo.
- Trial name
- NCT03490942
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 49 people
- Sponsor
- Xeris Pharmaceuticals
Tachyarrhythmia, Atrial Fibrillation
BIO.MASTER.BioMonitor 2 Study
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
- Conditions
- Tachyarrhythmia, Atrial Fibrillation, Syncope
- Trial name
- NCT02565238
- Testing
- BioMonitor 2
- Volunteers
- 92 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmias, Syncope
Study of New Implantable Loop Recorder
The goal of this IDE clinical study is to evaluate the quality of the cardiac signal recordings obtained by the St. Jude Medical (SJM) Confirm Implantable Cardiac Monitor (device).
- Trial name
- NCT00746564
- Testing
- SJM Confirm
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Abbott Medical Devices
Brain Injury
Efficacy Study of NH001 in Vegetative State & Minimally Conscious State Following a Traumatic Brain Injury
The purpose of this study is to test the drug apomorphine in subjects who are in a Vegetative State or a Minimally Conscious State.
- Trial name
- NH001-2 (NCT00761228)
- Testing
- Apomorphine
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- NeuroHealing Pharmaceuticals Inc.
Syncope, Pediatric
Pediatric Adhesion and New Dermal Approach Study
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease
- Trial name
- PANDA (NCT07118124)
- Testing
- Zio monitor
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- iRhythm Technologies, Inc.
Arrhythmias, Cardiac, Palpitation
Ambulatory Leadless Electrocardiogram Recorder Trial Feasibility
The goal of this study is to compare the heart signals that are received by a new heart monitoring device called the HeartWatch to heart signals that are recorded by existing monitors used in cardiology clinics today.
- Conditions
- Arrhythmias, Cardiac, Palpitation, Syncope, Light Headedness
- Trial name
- ALERT (NCT05821465)
- Testing
- HeartWatch
- Where
- Canada
- Volunteers
- 144 people
- Sponsor
- HelpWear Inc.
Motor Vehicle Accidents, TBI (Traumatic Brain Injury)
Concussion in Motor Vehicle Accidents: The Concussion Identification Index
The primary goal of this study is to provide clinicians with a brief, patient self-administer instrument yielding a single composite score that reliably correlates with objective findings on standardized neurocognitive assessment…
- Conditions
- Motor Vehicle Accidents, TBI (Traumatic Brain Injury), Brain Contusion, Brain Injuries
- Trial name
- CIDI (NCT02858544)
- Testing
- The Concussion Identification Index, ImPACT
- Where
- United States
- Volunteers
- 1,790 people
- Sponsor
- Clionsky Neuro Systems Inc.
Type 1 Diabetes Mellitus With Hypoglycemia
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.
- Trial name
- NCT03163511
- Testing
- VC-02 Combination Product
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 49 people
- Sponsor
- ViaCyte
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Bradycardia, Sinus Node Dysfunction
Physiologic Pacing Registry
The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements…
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT03719040
- Testing
- Physiologic pacing device implant
- Where
- 50 sites in United States, Australia and 14 more
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Syncope, Presyncope
Observational Study of the Sleuth Implantable ECG Monitoring System
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.
- Conditions
- Syncope, Presyncope, Fainting, Cardiac Arrhythmia
- Trial name
- OBSERV-ECG (NCT00717106)
- Where
- 8 sites in United States
- Volunteers
- 250 people
- Sponsor
- Transoma Medical
Syncope
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
- Trial name
- NCT00359203
- Testing
- Dual chamber pacemeker
- Where
- Italy
- Volunteers
- 511 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Anxiety, Stress
A Clinical Trial of De-stress and Focus Capsule in the Management of Stress.
The current study focuses in clinical validation of the efficacy of nutraceutical product in the management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement.
- Conditions
- Anxiety, Stress, Stuporous
- Trial name
- NCT06569849
- Testing
- De-Stress and Focus capsule- U001, De-Stress and Focus capsule - I001
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Herbolab India Pvt. Ltd.
Syncope, Presyncope
Sternal ECG Patch Comparison Trial
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system.
- Conditions
- Syncope, Presyncope, Palpitations, Atrial Fibrillation
- Trial name
- NCT02126631
- Where
- New Zealand
- Volunteers
- 50 people
- Sponsor
- Bardy Diagnostics, Inc.
Syncope, Cryptogenic Stroke
BIO|STREAM.ICM France
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system
- Trial name
- NCT04206774
- Where
- 3 sites in France
- Volunteers
- 92 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation, Syncope
BIO|CONCEPT.BIOMONITOR III
The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the…
- Conditions
- Atrial Fibrillation, Syncope, Tachyarrhythmia
- Trial name
- NCT03850327
- Testing
- BIOMONITOR III
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Biotronik SE & Co. KG
Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia
- Trial name
- Pilot'Ex (NCT05221359)
- Testing
- ExOlin®, Insulin aspart
- Where
- France
- Volunteers
- 8 people
- Sponsor
- Defymed
Symptomatic Neurogenic Orthostatic Hypotension, MSA
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
- Conditions
- Symptomatic Neurogenic Orthostatic Hypotension, MSA, Parkinson's Disease (PD), Pure Autonomic Failure (PAF)
- Trial name
- REDWOOD (NCT03829657)
- Testing
- ampreloxetine
- Where
- 82 sites in United States, Australia and 17 more
- Volunteers
- 203 people
- Sponsor
- Theravance Biopharma