View clinical trials related to Atrial Fibrillation.
Filter by:The purpose of this study is to use a decentralized claims database to determine whether education on stroke prevention in atrial fibrillation (AF) among AF patients and their providers can result in increased use of oral anticoagulants (OAC) for stroke prevention among those AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a prospective, randomized, open-label education intervention trial to evaluate the effect of the early patient and provider education interventions on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 international normalized ratio [INR tests] over the course of the follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time). A total of approximately 80,000 patients will be enrolled within multiple major health plans across the United States. The randomization will be performed by the central coordinating center, and the health plans will mail the educational intervention materials to their members and providers.
A random sample a random sample of half of all men born in 1943 and living in the city of Gothenburg, Sweden, have been investigated in 1993 at 50 years of age and will be followed continuously with repeated re-examinations and follow-up concerning mortality and cardiovascular diseased. Out of 1463 invited men, 798 (54.5%) accepted the invitation and is included in this longitudinal cohort study.
This study aims to compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications.
Study category and Rationale Clinical study, Category A. Clinical Phase: Post market study Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at the same time an at least equally good protection from strokes and peripheral embolism. It may therefore be an attractive alternative to oral anticoagulation in the patient population undergoing transcatheter aortic valve implantation (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here proposed "Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation", study we test the hypothesis, that LAAO is superior to standard medical therapy in the high-risk TAVI population. This hypothesis has not been investigated by previous studies so far. Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using the St. Jude left atrial appendage closure device with standard medical therapy in a prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical practice. Primary Objective: To assess the safety of the device intervention with regard to stroke prevention and prevention of bleeding complications in a patients population at high risk of stroke and bleeding. Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a further secondary objective, long-term effects of device intervention on stroke and bleeding prevention as well as mortality are assessed and compared to medical therapy. Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events, peripheral embolism, life-threatening/disabling and major bleeding complications and cardiovascular mortality at 1 year Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success at 30 days In-hospital acute kidney injury (AKI) Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers study Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis will be performed at 30 days and after completion of a 1-year follow-up. 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral anticoagulation alone). Estimated duration for the main investigational plan from start of screening of first participant to last participant processed and finishing the study: 6 years
Closure of the left atrial appendage in patients with atrial fibrillation and risk for stroke is a increasing technology leading to exclusion of the left atrial appendage volume from the blood circulation and therefore protects from cardioembolic strokes- It is unclear if the volume reduction of the left atrium leads to a change in exercise capacity or Quality of life.
Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents a high priority public health problem, as in a few decades it will become a possibly unsustainable load for the national health system. Preventive and therapeutic strategies based on the best possible scientific evidence are required. Ablation therapy, despite being the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective in primary prevention and reduced the incidence of AF in high-risk subjects in a recent, large, randomized trial (PREDIMED). Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1) intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of 0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12, 18 and 24 months. In addition to the in-person visits, event monitors will be used to document episodes. Dietary intervention will be carried out by nutritionists who will use methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per week will be provided for free in the intervention arm. Inflammatory markers will be analyzed in both groups during follow-up. Cox models will be used to estimate adjusted hazard ratios.
Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
Title: Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START): a pragmatic, adaptive randomized clinical trial. Primary Objective: • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation. Secondary Objectives: - To compare the rates of primary adverse outcomes in a per protocol analysis - To compare 30 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To compare 90 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC choice
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.