Active clinical trials for "Atrial Fibrillation"

Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have proven ineffective. Pulmonary vein isolation (PVI), in which circumferential ablation is performed around the ostia of the pulmonary vein - left atrial junctions, is the standard ablation approach internationally. Single-procedure success rates (1y, freedom from AF, off anti-arrhythmics) for patients with paroxysmal AF is roughly 70%, and even worse (roughly 50%) for patients with persistent AF. A number of strategies have been developed to improve outcomes in patients undergoing AF ablation, particularly in patients with persistent AF. Unfortunately, large prospective randomized trials (including STAR-AF II, published in NEJM in 2015) have demonstrated a failure of ancillary ablation techniques to improve AF ablation outcomes relative to PVI alone. In a collaborative effort between the Cardiology electrophysiology group and the Trayanova laboratory (Biomechanical Engineering), investigators have developed a strategy of patient-specific modeling to identify pro-arrhythmic sites in AF patients that may be amenable to ablation. In this approach, patients undergo a pre-ablation cardiac MRI with late gadolinium enhancement, to delineate regions of healthy atrial tissue and regions of scar (this scan is clinically indicated, and performed currently in patients undergoing PVI for AF). A novel in silico modeling to determine regions supporting electrical reentry in the atrium, driving ongoing AF, has been developed by the Trayanova lab. In preliminary studies, investigators have demonstrated the ability to identify and target these regions with catheter ablation in patients undergoing PVI. Investigators would like to conduct a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF. All patients enrolled would undergo standard pre-procedure imaging (LGE-MRI) prior to the day of procedure. Investigators have developed methodology termed OPTIMA (OPtimal Target Identification via Modeling of Arrhythmogenesis) to determine, based on non-invasive patient-specific anatomic and tissue data from late gadolinium enhancement cardiac MRI (LGE-CMR) and simulation of cardiac electrical function, personalized ablation targets for persistent AF in patients with fibrotic remodeling.. Patients would be randomized to receiving PVI only versus PVI + OPTIMA ablation at the time of ablation. Patients would then be followed in standard clinical fashion at 3m, 6m, and 12m to assess for ablation efficacy and for procedural complications. Investigators postulate a 20% improvement in freedom from AF with PVI + OPTIMA ablation form 50% to 70% (compared to PVI alone), investigators anticipate that in 1:1 randomization, a sample size of 80 patients in each arm will yield a power calculation of 80% with an alpha of 0.05. Investigators anticipate that enrollment and 1y clinical follow-up for 160 patients (total) undergoing AF ablation will require a 4y timeline.

Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)

Study name: Intensive management of blood pressure and cholesterol in elderly Chinese with hypertension and atrial fibrillation (IMPRESSION) Medicine: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); allisartan (240mg/tablet). Rationale: controlling blood pressure and cholesterol are both effective means to reduce cardiovascular risks, however, it is still unknown whether high cardiovascular risk patients with atrial fibrillation would benefit from intensive management of blood pressure and cholesterol. Objective: To evaluate the efficacy and safety of intensive management of blood pressure and cholesterol. Study design: This study is a multi-center, randomized and controlled clinical trial with four equally sized treatment groups: amlodipine/atorvastatin (5/10mg tablet); amlodipine/atorvastatin (5/20mg tablet); amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet); amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet). Study population: Men and Women aged over 65 years (n=1200) meeting the inclusion/exclusion criteria. Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into four groups, taking amlodipine/atorvastatin (5/10mg tablet) once a day or amlodipine/atorvastatin (5/20mg tablet) once a day or amlodipine/atorvastatin (5/10mg tablet)+allisartan (240mg/tablet) once a day or amlodipine/atorvastatin (5/20mg tablet)+allisartan (240mg/tablet) once a day. Follow up: 3 years. Sample size: a total of 1200 patients should be enrolled in the combination. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2019, recruitment will start. Patients enrollment will be performed between November 2019 to November 2020. All patients should be followed up before December 2023.

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.

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation (RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an AF ablation procedure. Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal sympathetic denervation (Intervention).

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 2% in general population. Incidence and prevalence of AF has been slightly increasing due to increasing age, improved ability to treat cardiac diseases, and higher incidence of obesity and other risk factors associated with AF. AF is associated with higher morbidity and mortality mainly caused by heart failure and stroke. Catheter ablation (with pulmonary vein isolation as a cornerstone) presents the most effective treatment method of AF. Recent observational studies have shown that intensive risk factor and lifestyle modifications, such as weight loss, reduced alcohol intake, and increased physical activity, are also associated with improved rhythm outocome. Head-to-head comparison of this very different methods has not been done yet. The aim of the project is to compare the effect of catheter ablation with lifestyle modification (risk factor modification) in a prospective, randomized, multicenter study on the maintenance of sinus rhythm (monitored using implantable ECG reveal), and on the progression of the fibrosis of the left ventricle.

Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Catheter ablation is a safe treatment option in eliminating AF however, success rates still remains variable. Existing strategies do not take into account the differences in AF perpetuation mechanisms beyond the pulmonary veins (PVs) due to the underlying substrate. Here, I will investigate the differences in persistent AF mechanisms due to the underlying substrate and utilise these findings to generate AF mechanism specific ablation strategies. I have defined a new metric, rate-dependent conduction velocity (RDCV) slowing that has shown to correlate with sites of re-entry activity in AF. In this study, techniques and methods will be developed to measure RDCV slowing sites. The impact autonomic modulation has on AF mechanisms and CV dynamics will also be assessed. The hypothesis is that a combination of structural, electrical and autonomic remodelling play an important mechanistic role in persistent AF and ablation strategies adapted to target these will result in greater procedural success rate. The study findings have the potential to improve the success rate of catheter ablation in persistent AF thereby improve patient wellbeing and reduce the cost burden of AF treatment.

Demonstrate initial safety and performance of Spatial Resynchronization Therapy (SRT) in patients with persistent atrial fibrillation.

Atrioventricular node ablation (AVNA) with biventricular (BiV) pacemaker implantation is a feasible treatment option in patients with symptomatic refractory atrial fibrillation and heart failure. However, conduction system pacing (CSP) modalities, including His bundle pacing and left bundle branch pacing, could offer advantages over BiV pacing by providing more physiological activation. The randomized, interventional, multicentric study will explore whether CSP is non-inferior to BiV pacing in echocardiographic and clinical outcomes in heart failure (EF <50%) patients with symptomatic AF and narrow QRS scheduled for AVNA.