View clinical trials related to Atrial Fibrillation.
Filter by:Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden. Rhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a "sham" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus "sham" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion. Understanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.
This will be a prospective, single-blinded, three-center, randomized, controlled trial comparing the effectiveness and safety of angioplasty guidewire-assisted transseptal puncture (GW-TSP) technique to transseptal left atrial (LA) access with conventional transseptal puncture with standard transseptal equipment (CON-TSP) in patients undergoing left atrial appendage occlusion (LAAO) procedure for atrial fibrillation. The targeted population will consist of patients with atrial fibrillation undergoing LAAO.
Given both the increasing population impact of atrial fibrillation (AF) and the widespread consumption of coffee in society, determining an associated benefit or risk of coffee consumption on AF is of great clinical relevance. This pilot study will evaluate the effect of randomly assigning participants undergoing electrical cardioversion to coffee abstinence or coffee consumption over a 6 month period. This pilot study will provide the first, randomized evaluation of coffee on AF outcomes and will provide important information on whether or not coffee has any effect on AF recurrence.
Atrial fibrillation (AF) is associated with increased mortality and morbidity, and is a dominant, yet preventable, cause of cardioembolic stroke, which has more severe outcomes than other ischaemic stroke causes if left untreated. Approximately 10% of ischemic strokes are associated with AF (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. Early diagnosis of AF might enable oral anticoagulant therapy and prevent unwanted consequences of undetected disease, leading to the suggestion that screening for AF might be beneficial in populations at risk. However, there is still debate about whether screen-detected AF bears a similar stroke and mortality risk profile to clinically detected AF, particularly when AF screening is done at a higher intensity than single-time point. The absence of studies reporting on hard clinical endpoints in AF screening has led to differences in recommendations globally. Most notably, systematic screening for AF is to be considered according to 2020 European guidelines, whereas the US Preventive Services Task Force concluded that current evidence is insufficient to assess the balance of benefits and harms of screening for AF. The incidence of screen-detected AF strongly depends on the population screened and duration/intensity of screening. Single-time point screening of a general population ≥65 years of age detects undiagnosed AF in 1.4%, and the AF detected is largely persistent. In a large population-based study of individuals 75 to 76 years of age, a more intense 2-week screening program using twice-daily intermittent handheld ECG recordings identified AF in 3.0% (0.5% on the initial ECG4). The identical protocol restricted to those with ≥1 additional stroke risk factor identified 7.4% with AF. This study was designed in to two arms. The purpose of Arm 1 is to upgrade the artificial intelligence by collecting the continued ECG monitoring data in patients with previous diagnosed AF. The purpose of Arm 2 is to investigate the detection rate of AF using systematic, intensive AF screening with continuous ECG monitoring and the rate of clinical outcome in individuals at high risk during one year follow-up.
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.
This is an extended follow up study of the original RAFT-AF Study. The RAFT-AF study was a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design. Patients were randomized to either catheter ablation-based rhythm control of AF as compared to rate control of AF
Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation (AF). Increased cardiac sympathetic stimulation can facilitate AF and reduction can be accomplished by renal artery denervation (RDN). The recently completed randomized trial, ERADICATE-AF, convincingly demonstrated that RDN plus PVI resulted in a reduction in recurrent incident AF for uncontrolled hypertensives. This is a randomized controlled pilot trial, "To Evaluate Renal Artery Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation" (ERADICATE-AF II) to test if RDN plus PVI enhances long-term efficacy vs PVI for persistent AF patients with controlled or without hypertension using implantable loop recordings.
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.
Today, 50 % of cardiac patients do not participate in cardiac rehabilitation due difficulties in navigating and accessing rehabilitation activities. HeRTA is a partnership project involving Center for Clinical Research and Prevention (CCRP), Hvidovre Hospital, Rehabilitation Center Albertslund and Copenhagen (municipalities), the Danish Heart Association, and local sports associations. A patient advisory board participate throughout the project to ensure a continued focus on patient interests. The overall aim of HeRTA is to develop and test the feasibility of a new, sustainable model for rehabilitation supporting patients to take part in rehabilitation and promoting life-long activity for all patients with heart disease. To ensure equal access to rehabilitation some activities are open to all patients, while others are tailored specifically to patients with vulnerability. The project unfolds in three phases: Development (1. January 1. 2020 - 14. November 2021): Partners and patients co-create content and procedures; Feasibility (15. November 2021 - 31. July 2023): The feasibility of the model is tested, and promising components are identified; Long-term follow-up and implementation (1. August 2023 - 31. December 2025): Long term effects are investigated and promising components are tested in new settings. During the feasibility phase the investigators will examine whether the intervention activities are feasible, acceptable, and may have positive effects for patients with heart disease. The investigators use qualitative data on implementation and acceptability of intervention among partners and patients. An randomisered controlled trial (RCT) component will assess effects on patient participation rates, health, physical activity level, and life quality. Data is collected from practitioners and patients through focus groups, observations, field notes, questionnaires, and interviews. Results will point to: - innovative ways to organize integrated rehabilitation pathways. - approaches to ensuring rehabilitation targeted at patient needs.