Clinical trials: Syncope
Arrhythmia, Palpitations
7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with…
- Conditions
- Arrhythmia, Palpitations, Syncope
- Trial name
- NCT07728552
- Testing
- MEMO Patch, 24-Hour Holter Monitor
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- HUINNO Co., Ltd
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
Bradycardia, Sinus Node Dysfunction
LBBAP Data Collection Registry
The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Heart Block, Syncope
- Trial name
- NCT05887323
- Testing
- Implantation of the Tendril 2088 lead in the LBBA
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 221 people
- Sponsor
- Abbott Medical Devices
Syncope, Cryptogenic Stroke
ConfirmRxTM: Posture and Activity
Insertable Cardiac Monitor's (ICM's) such as Confirm Rx™ are leadless devices implanted for long-term heart rhythm monitoring in the diagnosis and management of clinical conditions such as recurrent unexplained syncope…
- Trial name
- NCT03803969
- Testing
- ConfirmRx (Insertable Cardiac Monitor)
- Where
- 8 sites in Australia
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Orthostatic Hypotension, Reflex Syncope
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.
- Trial name
- ARISE (NCT07502599)
- Testing
- Wearable holter monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Unexplained Syncope, Suspected Arrhythmia
REVEAL for Respiration Detection
This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in…
- Trial name
- NCT01956578
- Testing
- Breathing Exercise Cohort
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
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
Syncope, Syncope, Vasovagal
Head-up Tilt Test in Patients With Reflex Syncope and Asystolic Response Who Received a Dual-chamber Pacemaker With the Closed Loop Stimulation (CLS) and Participated in the BIOSync Trial
The purpose of this study is to explore changes in patients' hemodynamic parameters during the Head-Up Tilt Test ("HUTT") and their timing with respect to onset of the Closed Loop Stimulation (CLS) pacing.
- Trial name
- BIO|Sync-HUTT (NCT06038708)
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Biotronik SE & Co. KG
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
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, 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.
Lennox-Gastaut Syndrome
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.
- Trial name
- LGS (NCT01160770)
- Testing
- Clobazam
- Volunteers
- 267 people
- Sponsor
- Lundbeck LLC
Arrhythmia
Study Evaluating GAP-486 in Heart Rhythm
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.
- Trial name
- NCT00137293
- Testing
- GAP-486 (ZP-123), 0.9% Sodium Chloride, USP
- Where
- 7 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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, 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
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
Orthostatic Hypotension, Reflex Syncope
Data Collection - Of Syncope Tilt Table Testing Study
To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.
- Trial name
- COST3 (NCT03721393)
- Testing
- Wearable heart monitor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Syncope, Presyncope
Abbott Brady 3T MRI PMCF
The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a…
- Conditions
- Syncope, Presyncope, Fatigue, Disorientation
- Trial name
- NCT03786640
- Testing
- 3T MRI scan
- Where
- 9 sites in Estonia, France and 3 more
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices