Clinical trials: Risk of Cardiac Arrhythmias
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
Atrial Fibrillation, Deep Vein Thrombosis
Association Between Genetic Variant Scores and Warfarin Effect
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism
- Trial name
- AWARE1 (NCT03894878)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
Atrial Fibrillation, Heart Failure
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event.
- Trial name
- IDENTIFY-HF (NCT01486316)
- Testing
- Reveal XT® Insertable Cardiac Monitor, Heart Failure Risk Status Diagnostic
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using…
- Trial name
- NCT07722078
- Volunteers
- 797 people
- Sponsor
- HUINNO Co., Ltd
Atrial Fibrillation, Vascular Risk
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in…
- Trial name
- NCT00243178
- Testing
- clopidogrel (SR25990C)
- Where
- 32 sites in United States, Australia and 30 more
- Volunteers
- 6,706 people
- Sponsor
- Sanofi
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
Atrial Fibrillation
Anticoagulants Comparative Benefit-risk Ratio in Real Life
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
- Trial name
- NCT02785354
- Where
- France
- Volunteers
- 103,101 people
- Sponsor
- Boehringer Ingelheim
Cardiac Resynchronization, Biventricular Pacemakers, Artificial
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS.
- Conditions
- Cardiac Resynchronization, Biventricular Pacemakers, Artificial, Cardioverter-Defibrillators, Implantable, Device Replacement
- Trial name
- BioCONTINUE (NCT02323503)
- Testing
- CRT-D device replacement
- Where
- 37 sites in Belgium, France and 6 more
- Volunteers
- 289 people
- Sponsor
- Biotronik SE & Co. KG
Tachyarrhythmia
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of…
- Trial name
- NCT00231426
- Testing
- ICD
- Where
- United States
- Sponsor
- Boston Scientific Corporation
Stroke, Hypertension
DELPHI in Subjects at Risk for Stroke and Dementia
The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories.
- Conditions
- Stroke, Hypertension, Diabete Mellitus, Dyslipidemias
- Trial name
- NCT03884647
- Testing
- DELPhI system
- Where
- 4 sites in United States, Israel
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- QuantalX Neuroscience
Myocardial Infarction, Arrhythmia, Ventricular
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305240
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 656 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Risk of Cardiac Arrhythmias
Reveal® XT Performance Trial (XPECT)
The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback…
- Trial name
- NCT00680927
- Testing
- 46 hrs Holter ECG recording
- Where
- 24 sites in Austria, Belgium and 6 more
- Volunteers
- 247 people
- Sponsor
- Medtronic BRC
Atrial Fibrillation
REVEAL AF: Incidence of AF in High Risk Patients
This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how…
- Trial name
- NCT01727297
- Testing
- REVEAL Implantable Cardiac Monitor
- Where
- 58 sites in United States, Austria and 5 more
- Volunteers
- 446 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World
The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better…
- Trial name
- NCT04276441
- Testing
- Heart healthy Engagement Program with the Apple Watch Series 5 or later, Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
- Where
- United States
- Volunteers
- 34,244 people, healthy volunteers welcome
- Sponsor
- Janssen Scientific Affairs, LLC
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Cardiac Pacemaker, Cardiac Rhythm Disorder
AVEIR Remote Care System Non-Significant Risk Study
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP…
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Trial name
- NCT06542133
- Testing
- AVEIR remote care system
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Esophageal Fistula
Retracting the Esophagus During AF Ablation
This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.
- Conditions
- Atrial Fibrillation, Esophageal Fistula, Cardiac Arrhythmia
- Trial name
- EsoSure (NCT02665442)
- Testing
- Esophageal Stylet - EsoSure
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Northeast Scientific, Inc.
Atrial Fibrillation, Atrial Flutter
A Study to Determine if Identification of Undiagnosed Atrial Fibrillation in People at Least 70 Years of Age Reduces the Risk of Stroke
The purpose of this study is to determine if an AF detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (AF) or atrial flutter (AFL) reduces the person-years incidence rate of…
- Trial name
- GUARD-AF (NCT04126486)
- Testing
- Zio®XT Monitor
- Where
- 176 sites in United States
- Volunteers
- 11,931 people
- Sponsor
- Bristol-Myers Squibb
Acute Myocardial Infarction
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction
The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several…
- Trial name
- NCT00145119
- Where
- Netherlands
- Volunteers
- 312 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Romano-Ward Syndrome, Long QT Syndrome
Evaluation of the Effects of KCNQ1 Mutation on Insulin Tolerance and Obsessive Compulsive Features in Long QT Romano-Ward Syndrome Patients.
The objectives of the study are to investigate if KCNQ1 mutation in Romano-Ward long QT patients can be associated with changes in insulin regulation and with psychological features of compulsivity, impulsivity and behavioural…
- Conditions
- Romano-Ward Syndrome, Long QT Syndrome, Compulsive Behavior, Healthy Individuals
- Trial name
- PRIME (NCT04715256)
- Testing
- Cognitive assessment of obsessive-compulsive and impulsive behaviours, Genomic analysis, Glucoregulation assessment
- Where
- 2 sites in France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biotrial