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32 active trials for Cardiac Arrhythmia

Accuracy of Cardiac Arrhythmias and Conduction Disorders Diagnosis Using a Smartwatch

Implantable devices increase the detection of silent atrial fibrillation in high-risk populations, being a useful tool in the early diagnosis of these patients, allowing monitoring for a longer time. Currently, these devices can be used for monitoring and possible early diagnosis of abnormalities in order to prevent health complications and bring about better outcomes, as well as monitor the user's progress and thus prevent more serious developments. Objective: to analyze, in patients with cardiovascular disease, the electrocardiographic aspects detected from the device in comparison to the conventional electrocardiogram, identifying aspects of similarity between the tracings obtained and automatic diagnostic accuracy by the device and by the visual assessment of the tracing. Method: a cross-sectional observational study of diagnostic accuracy will be carried out at the University Hospital of the Federal University of Piaui. The following parameters were considered: significance level of 95%, test power of 80%, value of the disease diagnosis rate of 84%, area under the receiver operating characteristic curve of 94% and an equal proportion of the number of positive and negative cases. The minimum sample size consisted of 100 patients, and an additional 10% will be added to compensate for possible losses. A total of 110 patients will be invited to participate in the study. Patients aged ? 18 years will be included, with the presence of one or more diagnoses below: systemic arterial hypertension, heart failure, valvular disease, coronary atherosclerotic disease, myocardial infarction, endocarditis, myocarditis, diabetes, cardiac arrhythmias and patients with cardiac pace or implantable automatic defibrillator. The variables analyzed will be: clinical-demographic data of the patients, including age, sex, race, socioeconomic profile; comorbidities and electrocardiographic findings as measured by the clock and conventional ECG. The data will be analyzed comparatively between the groups: 1 = EKG on the clock; 2 = 12-lead conventional EKG and DI (single lead). The primary outcome will be the positive diagnostic correlation of the data obtained in group 1 in relation to group 2. Secondary outcomes: successful measurement of the electrocardiographic record by the clock; diagnostic accuracy of atrial fibrillation and other heart rhythm disorders.

Start: June 2021

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

Start: December 2020

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with insulin-treated diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

Start: May 2021

Autonomic Nerve Stimulation Using External Auditory Canal Electrodes

Purpose of the study This study aimed to investigate electrocardiogram measurement and subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes among healthy adult participants Study design Prospective, single-center, interventional, single-arm design Study participants A total of 12 healthy adult participants without cardiovascular diseases will be recruited. Study methods Participant enrollment Study participants will be recruited by advertisement posters announced at the lobby of the hospital Evaluation of electrocardiogram measurement from external auditory canal electrodes Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared. Evaluation of low-level autonomic nerve stimulation using external auditory canal Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart.

Start: June 2021

Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured.

Start: April 2021

Mayo AVC Registry and Biobank

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: Discover new genes or altered genes (variants) which cause AVC Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

Start: January 2016

Proton Particle Therapy for Cardiac Arrhythmia

Researchers are gathering information on the safety and effectiveness of proton radiation therapy in reducing the number of ventricular tachycardia (VT) episodes in subjects who continue to experience VT despite treatment with an implantable cardioverter defibrillator (ICD) and undergoing a previous catheter ablation.

Start: March 2021

Remote Patient Management of CIEDs

This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

Start: May 2020

StereoTactic Ablative RadioTherapy of Cardiac Arrhythmias (START-CA)

This is a prospective, single-center, phase II trial that will be monitoring the safety and efficacy of using stereotactic ablative radiotherapy (SBRT) to treat patients with a medical condition affecting heart rate and rhythm (refractory arrhythmias) within the University Health Network (Princess Margaret Cancer Centre and Toronto General Hospital). The primary objective will be to prospectively monitor patient cardiac outcomes following SBRT.

Start: June 2021

Comparative Study of the Sternal Patch System With a Conventional Holter Recorder

This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.

Start: November 2020

The Effect of Energy Drink Ingredients on Cardiovascular Function in Men and Women 18-39 Years Old

Statement of the research question: Does the caffeine in energy drinks interact with other ingredients to affect cardiovascular function in healthy male and female adults after exercise? Purpose and significance of the study: Energy drinks are beverages promoted to enhance alertness along with athletic and cognitive performance. The most common ingredients found in energy drinks include water, sugar, caffeine, taurine, and B-vitamins, with variable inclusion of other ingredients, such as carnitine, glucuronolactone, inositol, guarana, ginkgo biloba leaf extract, thistle extract, and ginseng root extract. Since the mid-1990s, the consumption of energy drinks has grown dramatically, with worldwide sales in 2017 exceeding $49 billion. As the sale of energy drinks has grown, so has the number of adverse event case reports for patients who consumed energy drinks. Reported symptoms included cardiac arrhythmias such as ventricular fibrillation, atrial fibrillation, and cardiac arrest. A few small clinical studies have found that energy drinks can increase systolic and diastolic blood pressure and change electrical activity in the heart as measured by an electrocardiogram (ECG). The intent of the proposed study is to determine whether caffeine or the combination of caffeine with taurine and L-carnitine can alter cardiovascular function. Hypothesis: The effects of the ingredients of energy drinks on the heart are mediated in part by interactions between caffeine, taurine and carnitine. The amount of each ingredient in the study was based upon the amount commonly contained in two cans of energy drinks currently on the market.

Start: January 2020

Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization

BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality. However, additional clinical data on the short and mid-term improvement of CRT-D patients by the CRT AutoAdapt feature are needed.

Start: June 2021

N-Acetylcysteine Protection Against Radiation Induced Cellular Damage

Catheter ablation procedures (CAPs) are first line treatment for a great variety of cardiac arrhythmias. CAPs require X-Ray imaging; consequently, CAPs cause ionizing radiation (IR) exposure for patients. Exposure to IR, even at low-doses, increases individual risk of developing cancer. IR cause DNA damage directly and, mostly, indirectly by formation of cellular free radicals. Furthermore different response to IR results from inherited variants in genes involved in DNA damage repair. N-acetylcysteine (NAC) is an aminoacid that can directly neutralize free radicals and increase antioxidant systems. Our preliminary data suggest that IR exposure in patients undergoing CAP deranges the oxidative stress status and the pre-procedure intravenous administration of NAC could decrease such abnormality.

Start: September 2020

A Comparative Study of the QuoreOne Holter System and the Cardiolight Holter System

Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. Newer Holter monitors may provide some advantages over the more traditional ones. This study will compare the findings of a Holter exam using the QuoreOne system from QuoreTech with the traditional Cardiolight system from Cardios.

Start: January 2021

COvid-19 LongitUdinal Multiethnic BioImaging Assessment of CARDiovascular Sequelae Registry

COLUMBIA CARDS is a pilot study to understand how COVID-19 affects the heart. It is known that COVID-19 can affect the heart in different ways. COLUMBIA CARDS is studying why some COVID-19 survivors develop clinical conditions such as heart inflammation, fluid buildup, blood clots, and other cardiac problems during or after their COVID-19 illness, and why other ones do not. In this study, we will use cardiovascular magnetic resonance (CMR) and transthoracic echocardiography (TTE) to better understand the impact of COVID-19 on the heart.

Start: December 2020

Novel Cardiac Signal Processing System

This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems. The collected signals will then undergo BLINDED, CONTROLLED evaluation by unbiased electrophysiologist reviewer(s) to determine whether the PURE EP signals provides additional or clearer diagnostic information.

Start: November 2019

Use of "iSuite" During CMR-guided Electrophysiological Procedures

The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).

Start: January 2021

CLAIM: Using the KODEX-EPD System to Guide PaCing Lead Placements, A First In Man Study.

Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study: Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow. Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used; up until the part of the lead implantation workflow that is the scope of this investigation. As a bailout, when the operator declares failure to attempt.

Start: January 2021

Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.

The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.

Start: October 2020

High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

Start: August 2019