Clinical trials: Consciousness
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
Atrial Fibrillation (AF), Atrial Flutter
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT)
- Trial name
- Japan H2H (NCT07870837)
- Testing
- Application of ambulatory cardiac monitor
- Where
- 4 sites in Japan
- Volunteers
- 130 people
- Sponsor
- iRhythm Technologies, Inc.
Syncope
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.
- Trial name
- NCT00170261
- Testing
- Use of an Implantable Loop Recorder
- Where
- 3 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder
Aveir DR i2i Study
Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.
- Conditions
- Cardiac Pacemaker, Artificial, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT05252702
- Testing
- Aveir DR Leadless Pacemaker System
- Where
- 78 sites in United States, Austria and 11 more
- Volunteers
- 464 people
- Sponsor
- Abbott Medical Devices
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.
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
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
- Trial name
- ASAP (NCT02188147)
- Testing
- Short Term Wearable Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zoll Medical Corporation
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD)
PREPARE - Primary Prevention Parameters Evaluation
The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter…
- Conditions
- Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
- Trial name
- NCT00279279
- Testing
- Implanted Device
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Focal Seizure, Epilepsy
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure…
- Conditions
- Focal Seizure, Epilepsy, Focal Epilepsy
- Trial name
- FOCUS 2 (NCT07594119)
- Testing
- RAP-219
- Where
- 13 sites in United States
- Volunteers
- 312 people
- Sponsor
- Rapport Therapeutics Inc.
Multiple Myeloma
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form…
- Trial name
- NCT02921828
- Where
- 2 sites in United States, Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Syncope, Presyncope
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.
- Conditions
- Syncope, Presyncope, Palpitations, Atrial Fibrillation
- Trial name
- NCT02031484
- Where
- 4 sites in United States
- 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
Depression / Major Depressive Disorder, Depressed Mood
REM Sleep Disruption and Its Potential Uses in Depression Management
This randomized study evaluated whether brief wrist vibrations delivered through an Apple Watch during algorithm-identified rapid eye movement (REM) sleep could reduce depressive symptoms over approximately four weeks.
- Trial name
- NCT07891806
- Testing
- REM-Contingent Smartwatch Haptic Stimulation, Smartwatch Sleep Monitoring and Smart Alarm
- Where
- 2 sites in Romania
- Volunteers
- 208 people
- Sponsor
- WAKEZ HEALTH TECH ECOSYSTEM SRL
Disorders of Consciousness, Vegetative State
AI-Assisted Precision Hyperbaric Oxygen Therapy Based on Dynamic BIS-EEG Feedback for Patients With Disorders of Consciousness
Disorders of consciousness (DoC) are severe neurological conditions characterized by impaired awareness and reduced interaction with the environment.
- Conditions
- Disorders of Consciousness, Vegetative State, Minimally Conscious State
- Trial name
- AI-HBOT-DoC (NCT07855848)
- Testing
- AI-Assisted Personalized Hyperbaric Oxygen Therapy, Conventional Hyperbaric Oxygen Therapy
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Monitoring, Physiologic, Vital Signs
Bodytrak® Feasibility Study
Bodytrak® is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone…
- Conditions
- Monitoring, Physiologic, Vital Signs, Sepsis, Altered Level of Consciousness
- Trial name
- NCT03139955
- Testing
- Bodytrak
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Inova Design Solutions Ltd