Clinical trials: Consciousness Monitors
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
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
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
Syncope, Recurrent Symptomatic Atrial Fibrillation
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
- Trial name
- NCT01965899
- Testing
- Insertable Cardiac Monitor Implant
- Where
- 16 sites in Australia, Austria and 5 more
- Volunteers
- 151 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Atrial Fibrillation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia
- Trial name
- BIOSTREAM-ICM (NCT04075084)
- Where
- 31 sites in Australia, Czechia and 7 more
- Volunteers
- 1,400 people
- Sponsor
- Biotronik SE & Co. KG
Syncope, Pre-Syncope
Evaluation of a Mobile Cardiac Outpatient Telemetry System Versus Standard Loop Event Monitor
Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors in patients presenting with palpitations, syncope or near syncope occurring less frequently than every 24 hours.
- Conditions
- Syncope, Pre-Syncope, Palpitations
- Trial name
- NCT00295204
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Cardionet
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
Atrial Fibrillation, Syncope
LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study
The LUX-Dx PERFORM Study had two primary objects which were (1) to characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM)…
- Conditions
- Atrial Fibrillation, Syncope, Cryptogenic Stroke
- Trial name
- LUX-Dx PERFORM (NCT04732728)
- Where
- 24 sites in United States
- Volunteers
- 727 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Syncope
Feasibility Study: Sleuth Monitoring System
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
- Trial name
- PULSE (NCT00719277)
- Testing
- Sleuth Implantable ECG Monitoring System
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- Transoma Medical
ATRIAL FIBRILLATION, Syncope
BioMonitor Master Study
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation.
- Trial name
- BioMonitor (NCT01725568)
- Testing
- BioMonitor
- Where
- Germany
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable…
- Conditions
- Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia, Ablation
- Trial name
- Assert-IQ (NCT06172699)
- Testing
- Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device
- Where
- 11 sites in United States
- Volunteers
- 151 people
- Sponsor
- Abbott Medical Devices
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.
Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases
Effect of Anesthesia on Force Application During Colonoscopy
The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation.
- Trial name
- CFM (NCT02101099)
- Testing
- Colonoscopy Force Monitor
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Artann Laboratories
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, 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.