Active clinical trials for "Atrial Fibrillation"

In electrophysiology, interventional procedures are often assisted by fluoroscopic guidance, exposing both patients and healthcare professionals to a considerable dose of radiation. Catheter ablation of atrial fibrillation has frequently involved the use of fluoroscopy: in fact, it incorporates greater complexity due to the need to perform the transseptal puncture. A visible introducer in the 3D electro-anatomical mapping system (which does not involve the use of X-rays), has become an important tool for performing transseptal puncture: in particular, it is positioned at level of the oval fossa of the right atrium (puncture site); subsequently, the needle is introduced inside it; the intervention is guided both by electroanatomical mapping and by the use of intracardiac echocardiography for the identification of important anatomical landmarks. The "zero rays" technique represents a valid alternative to fluoroscopic guidance, widely used and validated over the years. In fact, X-ray exposure in an atrial fibrillation ablation procedure can reach up to 60 mSv: the radiological risk makes it necessary to study safe and effective alternative techniques. In this retrospective, observational and monocentric study, 50 catheter ablation procedures of atrial fibrillation will be examined, divided into two groups: 25 patients who performed this procedure according to the classic approach, ie under fluoroscopic guidance; 25 patients who performed this procedure using an ablative approach that involved the use of the introducer in combination with the 3D EAM system and intracardiac echocardiography. Clinical efficacy will be assessed through a cardiological checkup and 24-hour electrocardiographic recording (ECG Holter) at 6 months.

The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.

Atrial fibrillation (AF) is the most common arrhythmia affecting 1.3 million people in the UK. AF causes an irregular and fast heartbeat, which makes the heart pump poorly. As a result, blood clots may form inside the heart and, if they travel to the brain, can lead to an AF-related stroke. Patients with AF have a risk of stroke five-times higher than patients with normal rhythm. Anticoagulants make the blood less likely to clot and, thus, reduce the chances of an AF-related stroke. For most people, once anticoagulation is started it must be taken for the rest of their lives irrespective of the amount of AF someone has. However, anticoagulants make patients more prone to bleeding. New studies have reported a lower stroke risk in patients with short and infrequent AF episodes. If there are long time gaps in between AF episodes, short periods of anticoagulation around the time of AF may be enough to avoid clots from forming and reducing the overall risk of bleeding. To use anticoagulants only when needed will require an accurate and reliable way to detect AF when it occurs and alert patients. New technologies, such as small heart monitors placed under the skin, watches and rings, can track the heart rhythm continuously and send real-time alerts to patients via mobile phone message if AF is detected. The purpose of this study is to investigate if implantable cardiac monitors (LINQ II) and wearable devices (Apple Watch and CART-I ring) can detect AF episodes, send real-time alerts to patients and who will respond to these alerts within a short timeframe. The investigators will recruit 50 patients and follow them for six months. All participants will receive a LINQ II and a wearable device.

This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment

The fMRI study is a prospective study with the objective of evaluating the effects of the autonomic central nervous system on the regulation of heart rate in patients with atrial fibrillation (AF). This study will compare a functional MRI (fMRI) scan in patients prior to a direct current cardioversion (DCCV) to a second fMRI scan taken post DCCV. In addition, this study will compare functional MRI (fMRIs) to a control group of heart healthy, age-matched patients who will also receive two fMRI scans spaced about one week apart. Our expectation is that at the end of this study, the investigators will have greater insight into the role of the central nervous system and more specifically the autonomic nervous system in modulating AF. The investigators expect that understanding the interaction between the central nervous system and cardiac arrhythmias will lead to the development of novel therapies that preserve and restore normal sinus rhythm. This study will serve as a pilot study with the goal of obtaining additional grant funding and expanding the study once differences in volumes of activation are demonstrated.

Pulmonary vein isolation (PVI) has become a standard therapy for atrial fibrillation (AF), however, there is still considerable AF recurrence after PVI. Except for PV-left atrium (LA) reconnection, the cause of recurrence has been not yet fully clarified. The alternation of autonomic tone plays an important role in initiation of paroxysmal AF. It was reported that there are multiple gangliated plexus (GP) around pulmonary veins, therefore the modulation targeting those GPs, resulting in modulations of cardiac autonomic tone, have been conducted. Some study showed the efficacy of GP ablation for AF patients. According to the previous reports, heart rate (HR) increased, and heart rate variability (HRV) reduced after PVI. These are considered to be due to "autonomic denervation" caused by catheter ablation of GP. For the best of investigators knowledge, there have been no data on heart rate turbulence (HRT) of baroreflex sensitivity (BRS) concerning PVI.

The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk. This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome. Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.

This study will use an automated blood pressure monitor (Microlife WatchBP03) with an inbuilt algorithm to detect atrial fibrillation (an irregular heart rhythm) in patients with an implanted pacemaker who have previously documented paroxysmal (intermittent) atrial fibrillation. This study will compare the Microlife device detected atrial fibrillation episodes to the pacemaker detected atrial fibrillation episodes.

This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time. The occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies: How many stroke patients with atrial fibrillation are missed by standard stroke unit 24h- electrocardiography, and what is the effectiveness of the extended invasive and non-invasive ECG analysis tools to detect atrial fibrillation in stroke patients?