View clinical trials related to Atrial Fibrillation.
Filter by:Compelling evidences support the safety of direct oral anticoagulants (DOAC) compared to Vitamin K antagonists (VKA) in patients with non-valvular atrial fibrillation. The 2018 EHRA/ESC practical guide on the use of non-vitamin K antagonist oral anticoagulants stated that "data have shown that administration in a crushed form (e.g. via a nasogastric tube), does not alter the bioavailability for apixaban, rivaroxaban, and edoxaban". However, at the moment, there are no evidences supporting unequivocally the use of DOAC via PEG. The purpose of this study is to evaluate the safety and efficacy of Edoxaban administered through PEG in patients with an indication of anticoagulation according to the current clinical practice.
Current international guidelines recommend a three-month blanking period after pulmonary vein isolation (PVI) for atrial fibrillation (AF). Early recurrence of atrial tachyarrhythmia (ERAT; comprising of AF, left atrial tachycardia and atrial flutter) is common, occurring in up to 65% of patients, but in the first month is generally thought not to predict long-term AF recurrence, and re-intervention is not recommended. Suggested causes for ERAT include inflammation and arrhythmogenic structural changes caused by ablation lesions. Early, purely inflammatory ERAT would not lead to late AF recurrence as pulmonary vein reconnection is established as the main factor associated with long-term recurrence in paroxysmal AF. Previous studies have shown ERAT in the second to third month (rather than first month) to be a stronger predictor of late AF recurrence, due to presumed reduction in the contribution of the acute inflammatory response after this. Biochemical data have shown that the post-ablation inflammatory phase is usually limited to the first month after both radiofrequency (RF) and cryoballoon (CB) ablation, though inflammatory markers have been shown to be less elevated following CB PVI. Histologically, lesions formed by the two modalities differ significantly. RF lesions are characterised by irregular boundaries and significant disruption to the endothelium, exposing the sub-endothelial layer and resulting in significant and sustained platelet activation, changes which can last for many months. CB lesions on the other hand, are observed as well demarcated and homogenous within one week, with reduced thrombogenicity, which may lead to reduced inflammation. ERAT following CB ablation cannot be accurately predicted by inflammatory response and it is postulated that endothelial function may play a role in the development of ERAT in such patients. Some studies have shown reduced recurrence rate and re-hospitalisation amongst the CB population, including the FIRE and ICE trial, potentially resulting in a better patient experience with CB and the possibility of a shorter blanking period. Post-ablation inflammatory response is more predictive of ERAT following RF than CB PVI, and the latter is considered to be associated with less inflammation. There is however, a paucity of data evaluating endothelial function post-AF ablation and its correlation with ERAT or late recurrences of arrhythmia. Given that earlier re-intervention in patients with ERAT in the third month of the blanking period can result in greater outcomes with respect to late recurrence of AF, if it can be demonstrated that endothelial function testing in the first few months post-CB PVI can be predictive of later ERAT, then shortening the blanking period following CB PVI and performing repeat ablation to control troublesome later ERAT may reduce overall patient morbidity and re-hospitalisation. The purpose of this novel pilot study is to examine the relationship between the post-ablation inflammatory response, endothelial function and timing and frequency of ERAT for patients undergoing RF and CB PVI for paroxysmal or short-lived persistent (less than 6 months' duration) AF. If the initial data provides hypothesis generating information, the aim would be to perform the study on a larger basis with higher statistical power to determine whether early post-ablation endothelial function testing can predict recurrences and identify those suitable for earlier re-intervention.
The AFFELECT -study compares two types of treatment modalities for acute atrial fibrillation or flutter for patients in whom rhythm control is desirable. The main purpose is to observe if these arrhythmias can be safely treated electively (within 5-9 days). All patients are recruited in the emergency department. Patients must be in good clinical condition so that they can be discharged regardless to which treatment modality is randomly selected to them. Patients randomized to conventional care are treated conventionally which means acute rhythm control is applied by electrical or medical cardioversion in the emergency department (within 48 hours of onset of the arrhythmia). Patients randomized to elective care are discharged immediately after adequate temporary rhythm control is assured. All patients will visit a cardiologist out-patient clinic at approximately one week after the emergency room visit. Patients randomized to elective treatment and still in atrial fibrillation or in atrial flutter will be restored to sinus rhythm by electrical or medical cardioversion at the out-patient clinic. Cardiovascular status and treatment options are evaluated for all patients. Anticoagulation is managed according existing guidelines for all patients. Due to possibility of delayed cardioversion in the interventional group (elective care group), all patients receive anticoagulation before the out-patient clinic despite their thromboembolic risk. All patients who have not received adequate anticoagulation for three weeks prior to the delayed cardioversion will undergo a transesophageal cardiac ultrasound to ensure they are not in excess risk for thromboembolic events. Patients randomized to elective treatment have the possibility to opt-out and undergo acute cardioversion if their symptoms are unmanageable during the first week before the out-patient clinical. All patients are monitored for their symptoms by a standardized quality-of-life questionnaire and for possibly required acute medical interventions during the first week and one month after the out-patient clinic. After one month, all patients undergo an electrocardiography (ECG) to ensure the maintenance of normal rhythm in both treatment groups. After the months follow-up all patients are subsequently monitored for a maximum of five years for need of medical interventions due to atrial fibrillation of atrial flutter. New antiarrhythmics such as flecainide are not prescribed during the first month.
The project focuses on the evaluation of a novel, contactless monitoring technology to measure the blood pulsatile signal based on the video recording of an individual's face. The variability of the pulse rate is computed to identify the presence of atrial fibrillation (AF). We propose to enroll 315 patients with symptomatic AF, paroxysmal or persistent, who go through successful radiofrequency ablation or electrical cardioversion. A computer tablet will be used by the subjects at home during 14 days after their procedure to read emails, browse the internet and watch videos. Facial video recordings will be automatically acquired during these daily activities by the tablet device. The subject will be wearing an ECG patch during the follow-up period. The one-lead continuous ECG will be used as a reference to verify the presence of AF rhythm during facial video recordings. The primary aim of the study is to demonstrate the validity and robustness of the video-based technology to detect the presence of AF when facial videos are acquired by the patients at home.
Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA). The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner. The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.
Atrial fibrillation (AF) is the most common arrhythmia in western countries and causes of up to one quarter of ischemic strokes. The randomized eHealth-based Bavarian Alternative Detection of Atrial Fibrillation study (eBRAVE-AF) tests the efficacy of an e-health based strategy for the detection of AF. The e-health-based strategy consists of a smartphone-based photophlethysmographic (PPG) screening and an ECG-based validation.
High RF energy ablation of atrial fibrillation is fast, safe, less painful and effective procedure.
Atrial fibrillation patients with risk factors for stroke and systemic embolism require long-term anticoagulant therapy. Recently, non-vitamin K antagonist oral anticoagulant (NOAC) has shown their excellent safety and efficacy, and thus are widely accepted in clinical practice. Meanwhile, after percutaneous coronary intervention (PCI) using the drug-eluting stents due to coronary artery disease, the administration of one or more antiplatelets is essential to prevent the recurrence of stent thrombosis and myocardial infarction. Combined administration of anticoagulants and antiplatelets significantly lowers the incidence of ischemic events such as stroke and myocardial infarction, however, it also significantly increases the likelihood of bleeding leading to hospitalization, and or even death, thereby significantly affecting the clinical course of the AF patients who underwent PCI. Nevertheless, due to the very high mortality rate of stent thrombosis, the current standard of care guidelines recommend triple therapy with anticoagulants and double antiplatelet therapy (DAPT) in patients with atrial fibrillation for 1 month after coronary intervention, followed by co-administration of NOAC with single antiplatelet agent for 1 year. However, little is known after the optimal therapeutic strategy after 1 year. The purpose of this study is to compare the clinical results of single anticoagulant and clopidogrel combination therapy for maintenance therapy after 1 year in patients with atrial fibrillation.
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto [generic name rivaroxaban], Eliquis [generic name apixaban] or Pradaxa [generic name dabigatran]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism [effectiveness]) and intracranial hemorrhage a type of bleeding that occurs inside the skull [safety]).