View clinical trials related to Atrial Fibrillation.
Filter by:Heart failure (HF) is a condition in which the heart cannot pump blood adequately. It is increasingly common, consumes 4% of the UK National Health Service (NHS) budget and is deadlier than most cancers. Early diagnosis and treatment of HF improves quality of life and survival. Unacceptably, 80% of patients have their HF diagnosed only when very unwell, requiring an emergency hospital admission, with worse survival and higher treatment costs to the NHS. This is largely because General Practitioners (GPs) have no easy-to-use tools to check for suspected HF, with patients having to rely on a long and rarely completed diagnostic pathway involving blood tests and hospital assessment. The investigators have previously demonstrated that an artificial intelligence-enabled stethoscope (AI-stethoscope) can detect HF in 15 seconds with 92% accuracy (regardless of age, gender or ethnicity) - even before patients develop symptoms. While the GP uses the stethoscope, it records the heart sounds and electrical activity, and uses inbuilt artificial intelligence to detect HF. The goal of this clinical trial is to determine the clinical and cost-effectiveness of providing primary care teams with the AI-stethoscope for the detection of heart failure. The main questions it aims to answer are if provision of the AI-stethoscope: 1. Increases overall detection of heart failure 2. Reduces the proportion of patients being diagnosed with heart failure following an emergency hospital admission 3. Reduces healthcare system costs 200 primary care practices across North West London and North Wales, UK, will be recruited to a cluster randomised controlled trial, meaning half of the primary care practices will be randomly assigned to have AI-stethoscopes for use in direct clinical care, and half will not. Researchers will compare clinical and cost outcomes between the groups.
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together >4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, >5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.
Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension. Atrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality . (AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) . It's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use.
The goal of this observational study is to learn about The Atherogenic Index of Plasma(AIP) in patients with atrial fibrillation(AF). The main questions it aims to answer are: (1)To investigate the correlation between AIP and the occurrence rate of AF. (2) To investigate the correlation between AIP and the occurrence rate of cardiovascular outcome events (MACE events, heart failure, embolism events) in patients with AF. Patients's clinical data including medical history, laboratory tests, and imageological examination will be collected and further analysed.
The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. The main question to answer is whether taVNS will reduce the heart rate in patients with persistent atrial fibrillation. After appropriate training, participants will self-administer taVNS for 30 minutes every day for two weeks. During one of the two weeks (randomized order), the clip electrode, delivering the electrical current will be attached to the cymba conchae of the left ear, while during the other week the clip electrode will be attached to the lobule of the left ear. During both weeks, the electrocardiogram (ECG) will be monitored continuously through a small ECG patch that is placed on the chest. Participants will meet with the investigators at the beginning of the study, after 7 days and at the end of the study (after 14 days). Researchers will compare the ECG obtained during the two weeks and evaluate if the heart rate differs between the two study weeks.
Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and different rates and types of complications. (2) The efficacy over a mean follow-up of one year with cryoablation for AF is comparable to that of radiofrequency ablation in a prospective randomized trial, with a lower major complication rate (3, 4). In recent years, AF cryoablation has established itself as a real alternative to RF ablation, to the point that this ablative source is chosen in one out of five European patients undergoing PV isolation. 70-80% of patients maintain sinus rhythm after a first procedure, showing an efficacy rate equivalent to ablation by RF. It is also comparable to RF when it comes to safety. Phrenic nerve palsy remains the major concern of cryoablation, accounting for 40% of periprocedural complications. A reduction in total procedure time and less dependence on the operator's experience make cryoablation an attractive choice for centres starting an AF ablation program. In conclusion, we do not yet have definitive data to affirm the superiority of one energy source over the other. Generally the choice depends on the availability of the centre and on the experience of the operator. Pulse field ablation (PFA): Vivek Y. Reddy demonstrates that in patients with paroxysmal atrial fibrillation, PFA rapidly and efficiently isolates PVs with a degree of tissue selectivity and a safety profile(1).PFA can achieve a high degree of durable PV isolation with a comparable efficiency than another techniques (RF or CRYO) at one year follow-up (2) Cryoablation has been a recognised technique for the ablation of atrial fibrillation for many years, with many studies comparing the technique to radiofrequency ablation with equal results. Studies are underway to compare radiofrequency AF ablation versus PFA (BEAT-AF study). A randomized study to compare two methods of cryoablation versus PFA will be necessary to validate the non-inferiority of the technique.
The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are: - Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF? - Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular; - Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor, - Regular echocardiographic exams for reverse atrial remodelling assessment, - HRQoL questionnaires - Assessment of cognitive function - Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression - Assessment of Health care use and costs - Safety
Atrial fibrillation is the most common sustained cardiac arrhythmia (rhythm abnormality) encountered in clinical practice. It contributes significantly to the risk of cardiac symptoms, hospital admissions, cardiovascular related morbidity and mortality and increased healthcare cost. AF has significant impact on healthcare cost. The major drivers of the cost are hospitalisations, stroke and loss of productivity. Globally AF accounts for less than 1% of all deaths. However, because it co-exists with other conditions, it contributes to worse prognosis compared to persons who do not have AF. New onset AF in HF patients may be associated with particularly poor prognosis. Most of the published data and current knowledge on AF epidemiology are based on studies in Europe and North America. The information obtainable from previous studies in sub-Saharan Africa is limited. Many of the studies were retrospective. There is also paucity of information on burden of AF (both in hospital and community), clinical profile and outcome of AF in Nigeria in particular and Africa in general. The primary objective of this study is to determine the clinical characteristics, outcome as well as cost genetic features of AF in Nigeria. The project will provide information on: i. Hospital and community burden of AF in Nigeria; ii. Clinical features, mode of presentation and risk factors for AF; iii. Provide data on AF related outcomes as well as prognostic factors.
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure. Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).