View clinical trials related to Atrial Fibrillation.
Filter by:The COR advance study is a non-randomized prospective single center study to assess the results of an electrophysiologically guided approach for PV cryoablation using the Arctic Front Advance ST® catheter together with the Achieve® mapping catheter in 25 patients with drug-refractory paroxysmal AF. Methods Patient selection criteria will be the same that in the original COR study. All patients will be followed with a Reveal LINQ® cardiac monitor that will be implanted before ablation. The primary objective is the proportion of patients remaining free from atrial fibrillation recurrences without taking antiarrhythmic drugs 12 months after ablation. Secondary objectives are: AF-free survival without anti arrhythmic drugs 12 months after ablation, cumulative AF burden (number of AF episodes and percentage of time in AF) 12 months after ablation, percentage of the pulmonary veins with bidirectional block at the end of the procedure, and ablation time (from the onset of the first energy delivery to the end of the last energy delivery), procedure time (from femoral puncture to catheter removal), and fluoroscopy time. Final results will be known 24 months after the first enrollment. Statistical analysis Continuous variables that are distributed normally according to the Shapiro-Wilk test will be presented as the mean [standard deviation], and the values will be compared with the t test. Continuous variables that do not follow a normal distribution will be presented as the median [25th to 75th percentile] and will be compared with the Mann-Whitney U test. Categorical variables between two groups with expected values <5 will be compared with the Fisher exact test. Otherwise, categorical variables will be compared with the chi-squared test. The AF-free survival functions will be represented as Kaplan-Meier curves. Data analyses will be done with JMP® (version 9.0.1, SAS Institute Inc., Cary, NC, USA) and Stata® (version 11.0, StataCorp LP; College Station, TX, USA).
Arterial hypertension has been recognized as a major causal factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. In light of its worldwide increasing prevalence and incidence and the accompanied increase in the risk of stroke, thromboembolic events and mortality, AF has emerged as a global healthcare problem. Early diagnosis of AF, prior to the occurrence of complications is a recognized priority for the prevention of strokes. Once diagnosed, anticoagulant therapy is the cornerstone in the management of the risk of stroke in AF patients. The 2012 ESC Guidelines recommend the use of a risk factor-based approach to stroke risk stratification for AF patients. This study aims towards gaining real-world data on the prevalence of non-valvular atrial fibrillation (NVAF) among hypertensives in Greece. The rate of ESC guideline-adherent antithrombotic therapy on the basis of stroke and bleeding risk assessments, and factors influencing treatment decision-making will be assessed as well in patients diagnosed with the arrhythmia. Finally, potential differences in the NVAF prevalence in adequately and inadequately controlled hypertensives will be documented.
Paroxysmal atrial fibrillation is often undetected because characteristics such as short duration, episodic, and frequently asymptomatic nature make it challenging to diagnose at the bedside, leading to suboptimal secondary prevention. It is not uncommon for paroxysmal atrial fibrillation to be undetected in a single electrocardiogram (ECG) on admission. Conventional 24-hour Holter monitoring is often used to detect paroxysmal atrial fibrillation. However, systematic review suggests Holter monitoring will identify atrial fibrillation in only an additional 4.6% of patients, no better than detection rates observed in groups lacking routine monitoring. On the other hand, for ischemic stroke patients with sinus rhythm at baseline but paroxysmal atrial fibrillation still suspected, no recommendation beyond repeated 12-lead ECGs is made in the United Kingdom guideline. Serial 12-lead ECG has been used to detect possible paroxysmal atrial fibrillation among acute ischemic stroke patients and found 15 new cases of atrial fibrillation in 133 acute ischemic stroke patients (11.3%) without atrial fibrillation at baseline. The optimal investigation strategy, including modality, duration of investigation, and patient subgroup remains undefined, not only for efficacy in the detection of atrial fibrillation, but also cost-effectiveness in healthcare systems. The objective of this project is to conduct a pragmatic multicenter randomized controlled trial for the comparison of serial 12-lead ECG once daily for 5 days and 24-hour Holter to detect paroxysmal atrial fibrillation in acute ischemic stroke patients without atrial fibrillation identified by baseline ECG or history.
The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study. The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials. The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI>15.
In this study, the investigators aim to identify and characterize, by means of an EnSite Velocity Research Software, the electrophysiological characteristics of substrates that sustain AF in patients with persistent AF and to test whether ablation of such patient-specific substrates might improve the acute and long-term success of conventional catheter ablation therapy.
The goal of this study is to learn about the patient and provider perceptions, priorities, preferences, and willingness to use/prescribe anticoagulation as a stroke prevention therapy in patients with atrial fibrillation. Qualitative interviews will be performed with atrial fibrillation patients and providers caring for atrial fibrillation patients. The investigators want to understand the factors that influence decision-making about anticoagulation medications, and to gain insight into patients' and providers' knowledge of the risk of stroke and bleeding associated with oral anticoagulation. This feedback will help provide better education to providers caring for patients with atrial fibrillation and better care to patients with atrial fibrillation by developing tools to optimize the appropriate use of oral anticoagulation for patients with atrial fibrillation.
Use of new oral anticoagulants (NOAC) in patients before and after catheter based pulmonary vein isolation (PVI) is still controversial. Experience is reported from consecutive patients ablated with PVI for atrial fibrillation and treated with dabigatran, rivaroxaban, or apixaban from Nov 2011 until Dec 2014. Patients are followed for 3 month after ablation. All complications possible being related to the use of NOAC are registered.
There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with oral anticoagulation. These patients are currently treated with vitamin K antagonists, DOACs, antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive alternative in terms of a low risk of recurrent ICH, while at the same time being effective for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage who are treated with apixaban versus those who are treated with antiplatelet drugs or no antithrombotic drug at all. This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded outcome assessment design.
The objective of the study is to confirm safety and efficacy of the BioMonitor 2. The data is collected to support the regulatory approval of this product in countries outside the CE region.
Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.